Prosthetic heart valve

ABSTRACT

This disclosure relates generally to prosthetic valves and methods and systems for deploying, positioning, and recapturing the same. A prosthetic valve includes one or more support structures. At least one of the one or more support structures defines an elongate central passageway of the prosthetic valve. The prosthetic valve can also include a plurality of leaflet elements attached to at least one of the one or more support structures and disposed within the elongate central passageway for control of fluid flow through the elongate central passageway. At least one of the one or more support structures is configured to biodynamically fix the prosthetic valve within a native valve such as, for example, a native tricuspid valve of a heart.

CROSS-REFERENCE TO RELATED APPLICATION

This Application is a Continuation of U.S. application Ser. No.16/836,882, filed Mar. 31, 2020, entitled “PROSTHETIC HEART VALVE”,which is a Continuation of International Patent Application Serial No.PCT/US2020/024765, filed Mar. 25, 2020, entitled “PROSTHETIC HEARTVALVE”, which is a Non-Prov of Prov (35 USC 119(e)) of U.S. ApplicationSer. No. 62/823,365, filed Mar. 25, 2019, entitled “PROSTHETIC HEARTVALVE”. The entire contents of these applications are incorporatedherein by reference in their entirety.

TECHNICAL FIELD

The present disclosure generally relates to implantable cardiac devicesand, more particularly, to prosthetic tricuspid valves.

BACKGROUND

Significant advancements have been made in the transcatheter treatmentof heart valve disease. Initial clinical efforts focused on thepulmonary valve and were quickly followed by devices focused on thepercutaneous replacement of the aortic valve to treat Aortic Stenosis.In parallel there were numerous programs that attempted to addressMitral Regurgitation through transcatheter repair technologies and laterthrough transcatheter mitral valve replacement.

Tricuspid valve disease is a condition in which the tricuspid valvelocated between the right ventricle and the right atrium of the heart ofdoes not function properly. There are multiple forms of tricuspid valvedisease, including, for example, tricuspid valve regurgitation, in whichblood flows backwards from the right ventricle into the right atrium,tricuspid valve stenosis, in which the tricuspid valve is narrowed,thereby decreasing blood flow from the right atrium to the rightventricle, and tricuspid atresia, which is congenital non-formation ormal-formation of the tricuspid valve, thereby blocking or decreasingblood flow from the right atrium to the right ventricle. Tricuspid valvedisease has been largely ignored as a “lesser” valve disease, relativeto Aortic Stenosis (greatest level of mortality) and MitralRegurgitation (greatest prevalence).

There are currently few tricuspid-specific prosthetic tricuspid valves.In many cases tricuspid valve defects have been treated using repurposedprosthetic aortic and mitral valves. Prosthetic aortic and mitral valvesthat have been repurposed for use in the tricuspid valve rigidly fix byasserting pressure on the native annulus of the tricuspid valve, makingthe prosthetic valve immobile. Because of the tricuspid valve'sproximity to conductive regions of the heart, this rigid fixation of aprosthetic valve within the tricuspid valve can lead to heart blockand/or other conduction abnormalities.

There is a need for prosthetic valves specifically designed for therepair of the tricuspid valve, as replacement of the tricuspid presentsunique issues.

SUMMARY

The invention provides a prosthetic tricuspid valve that is not rigidlyfixed within a native tricuspid valve. This biodynamic valve designprevents heart blockage and/or other dangerous conduction abnormalities.The prosthetic tricuspid valve provided herein is able to remain inplace stably, but not rigidly throughout the cardiac cycles of the heartis also needed.

The biodynamic prosthetic heart valve of the invention provides thenecessary solutions by allowing the needed movement which characterizesthe native tricuspid valve. In one aspect, the invention comprises aprosthetic heart valve including one or more support structures. Atleast one of the one or more support structure defines an elongatecentral passageway. The prosthetic heart valve can also include aplurality of leaflet elements attached to at least of the one or moresupport structures and disposed within the elongate central passagewayfor control of blood flow through the elongate central passageway. Atleast one of the one or more support structures is configured tobiodynamically fix the prosthetic heart valve to native leaflets of anative heart valve of a heart. Specifically, in some embodiments, the atleast one support structure is configured to biodynamically fix theprosthetic heart valve to the native leaflets of the native heart valvesuch that the at least one support structure is moveable within a nativeannulus of the native heart valve responsive to changes in pressure onone or more sides of the native heart valve.

As referred to herein, the term “biodynamic” with regard to a prostheticheart valve, refers to a configuration of the prosthetic heart valvethat allows the prosthetic heart valve to maintain axial stabilizationwithin a native heart valve of a heart, while also moving within thenative heart valve. This allows the valve to be responsive toalternating pressure differentials on either side of the native heartvalve during cardiac cycles of the heart. This is accomplished withoutdirectly attaching to a native annulus or native chords of the nativeheart valve, thereby preserving the natural motion of the nativeannulus. Specifically, the prosthetic heart valve is axially stabilizedwithin the native heart valve by grasping the native leaflets of thenative heart valve, rather than relying on annular force or directannular or chordal attachment. As referred to herein, the term “axialstabilization” with regard to a prosthetic heart valve located within anative heart valve refers to a portion of the prosthetic heart valvebeing interposed between any two diametrically opposed points on anative annulus of the native heart valve.

Many features of the prosthetic heart valve described herein enable thisbiodynamic movement of the prosthetic heart valve. In some embodiments,at least one of the one or more support structures of the prostheticheart valve includes a cylindrical portion having an atrial end and aventricular end. The elongate central passageway of the prosthetic heartvalve is defined by the cylindrical portion of the at least one supportstructure. In some embodiments, at least one support structure of theone or more support structures comprises an atrial set of arms.Additionally, in some embodiments, at least one support structure of theone or more support structures comprises a ventricular set of arms. Eacharm of the atrial set of arms and the ventricular set of arms caninclude a proximal segment that is proximal to the cylindrical portionof the at least one support structure and a distal segment that isdistal to the cylindrical portion of the at least one support structure.

In some embodiments, the distal segment of each arm of the atrial set ofarms and the ventricular set of arms can extend perpendicularly awayfrom a central axis of the elongate central passageway. Furthermore, theatrial set of arms can be configured to contact the native leaflets onan atrial side of the native heart valve, and the ventricular set ofarms can be configured to contact the native leaflets on a ventricularside of the native heart valve. As referred to herein, a distal segmentof an arm extending “perpendicularly” away from the central axis of theelongate central passageway refers to the distal segment of the armextending away from the central axis of the elongate central passagewaysuch that that a line drawn from a point of contact of the distalsegment with an object (e.g., a native heart valve leaflet) to alongitudinal position along the exterior surface of the cylindricalportion of the at least one support structure from which the distalsegment extends, is oriented approximately 90° +/−45° from the centralaxis of the elongate central passageway. As discussed below, thisapproximate perpendicularity of the line from the point of contact ofthe distal segment to the longitudinal position along the exteriorsurface of the cylindrical portion from which the distal segment extendsenables axial stabilization of the prosthetic heart valve within thenative heart valve.

Specifically, in some embodiments, the atrial and ventricular sets ofarms are bent such that in an implanted configuration in which the atleast one support structure biodynamically fixes the prosthetic heartvalve to the native leaflets of the native heart valve, in the event ofmotion of the cylindrical portion of the at least one support structuretoward the atrial side of the native heart valve due to a ventricularsystolic pressure load, one or more arms of the ventricular set of armsresist the motion while one or more arms of the atrial set of arms relaxto maintain contact with the atrial side of the native leaflets.Similarly, in the event of motion of the cylindrical portion of the atleast one support structure toward the ventricular side of the nativeheart valve due to a ventricular diastole pressure load and/or anelimination of a previously applied ventricular systolic load, one ormore arms of the atrial set of arms resist the motion while one or morearms of the ventricular set of arms relax to maintain contact with theventricular side of the native leaflets. This also creates a trampolineeffect where the ventricular systolic pressure load can be partiallyabsorbed by the atrial motion of the native leaflets.

In some embodiments, the arms of the atrial set of arms alternate withthe arms of the ventricular set of arms around a circumference of thecylindrical portion of the at least one support structure.

In some embodiments, overbite can exist between the atrial set of armsand the ventricular set of arms. Specifically, in some embodiments, thearms of the atrial set of arms and the arms of the ventricular set ofarms can extend across a cross-sectional plane of the cylindricalportion of the at least one support structure. As referred to herein, a“cross-sectional plane” with regard to a cylindrical portion of at leastone support structure is a cross-sectional plane of the cylindricalportion of the at least one support structure that is perpendicular to acentral axis of a elongate central passageway defined by the cylindricalportion of the at least one support structure. In some furtherembodiments, the distal segments of the arms of the atrial set of armsthat extend perpendicularly away from the central axis of the elongatecentral passageway extend toward the ventricular end of the cylindricalportion of the at least one support structure, thereby enabling thedistal segments of the arms of the atrial set of arms that extendperpendicularly away from the central axis of the elongate centralpassageway to clamp the native leaflets on the atrial side of the nativeheart valve. Additionally, the distal segments of the arms of theventricular set of arms that extend perpendicularly away from thecentral axis of the elongate central passageway can extend toward theatrial end of the cylindrical portion of the at least one supportstructure, thereby enabling the distal segments of the arms of theventricular set of arms that extend perpendicularly away from thecentral axis of the elongate central passageway to clamp the nativeleaflets on the ventricular side of the native heart valve.

Upon implantation of the prosthetic heart valve, this overbite betweenthe atrial arms and the ventricular arms will result in additionalclamping action and further tensioning of the native leaflets becausethe distal segments of the atrial arms on the atrial side of the nativeleaflets will be actively pushing down towards the ventricle of theheart, while the distal segments of the ventricular arms on theventricular side of the native leaflets will be actively pushing uptowards the atrium of the heart, thereby effectively creating acorrugated effect in the native leaflets like a ruffled collar. Thistensioning effect from the opposing forces on either side of the nativeleaflets will help to further axially stabilize the prosthetic heartvalve within the native heart valve. The amount of overbite between theatrial arms and the ventricular arms of the prosthetic heart valvedetermines the magnitude of the clamping force of the arms on the nativeleaflet of the native heart valve. Furthermore, the magnitude of theclamping force of the arms on the native leaflets of the native heartvalve determines the amount of axial stabilization and biodynamicmovement of the prosthetic heart valve within the native heart valvethroughout cardiac cycles of the heart. Specifically, greater clampingforces of the arms on the native leaflets of the native heart valveyields greater axial stabilization and less biodynamic movement of theprosthetic heart valve within the native heart valve throughout cardiaccycles of the heart.

In some embodiments, the distal segments of the arms of the atrial setof arms that extend perpendicularly away from the central axis of theelongate central passageway each have a tip that curves toward theatrial end of the cylindrical portion of the at least one supportstructure, thereby reducing trauma to the native leaflets on the atrialside of the native heart valve at the points of contact of the atrialset of arms. Furthermore, in some embodiments, the distal segments ofthe arms of the ventricular set of arms that extend perpendicularly awayfrom the central axis of the elongate central passageway each have a tipthat curves toward the ventricular end of the cylindrical portion of theat least one support structure, thereby reducing trauma to the nativeleaflets on the ventricular side of the native heart valve at the pointsof contact of the ventricular set of arms.

In some embodiments, the cylindrical portion of the at least one supportstructure can be radially collapsible for transcatheter implantation.Additionally, the distal segments of the atrial and ventricular sets ofarms that extend perpendicularly away from the central axis of theelongate central passageway can be resiliently straightenable.

In certain embodiments, the distal segments of one or more arms of theventricular set of arms (e.g., ventricular-directed arms) that extendperpendicularly away from the central axis of the elongate centralpassageway, can extend toward the ventricular end of the cylindricalportion of the at least one support structure, thereby enabling thedistal segments of the ventricular-directed arms that extendperpendicularly away from the central axis of the elongate centralpassageway to contact one of the native leaflets on the atrial side ofthe native heart valve rather than on the ventricular side of the nativeheart valve, thereby holding the native leaflet radially outward fromthe native heart valve in an open position. Configuring theventricular-directed arms to hold a native leaflet radially outward froma native heart valve in an open position can be useful in many differentembodiments. For example, configuring the ventricular-directed arms tohold a native leaflet radially outward from a native heart valve in anopen position can be useful in embodiments in which the native leafletis difficult to capture by the arms for one reason or another (e.g., ifthe native leaflet is too small or restricted). As another example,configuring the ventricular-directed arms to hold a native leafletradially outward from a native heart valve in an open position can beuseful in minimizing a number of echocardiography planes and/orviewpoints required during implantation of the prosthetic heart valve(thereby simplifying the implantation procedure).

In some embodiments, the prosthetic heart valve described herein canfurther include one or more covers that extend within the elongatecentral passageway and over one or more of the atrial set of arms andthe ventricular set of arms. In some such embodiments, a portion of theone or more covers can include a fenestration feature. In an implantedconfiguration in which the at least one support structure biodynamicallyfixes the prosthetic heart valve to native leaflets of a native heartvalve, the fenestration feature can be disposed between the elongatecentral passageway and a native annulus of the native heart valve. Insome embodiments, the fenestration feature can be at least one of aradiopaque marker, an opening, a magnetic element, a one-way valve, apop-up valve, a mechanically resizable opening, and increased porosity.

In certain embodiments, the atrial set of arms of the prosthetic heartvalve can be attached to the ventricular end of the cylindrical portionof the at least one support structure, while the ventricular set of armscan be attached to the atrial end of the cylindrical portion of the atleast one support structure. In other words, in certain embodiments, theatrial set of arms and the ventricular set of arms of the prostheticheart valve can originate from opposing ends of the cylindrical portionof the at least one support structure. In such embodiments, the one ormore covers can initiate at and attach to the distal segment of each armof the atrial set of arms, extend to and attach to the proximal segmentof each arm of the ventricular set of arms, extend through thecylindrical portion of the at least one support structure within theelongate central passageway, and extend around the cylindrical portionof the at least one support structure to attach to the proximal segmentof each of the atrial set of arms. In some embodiments, the one or morecovers can terminate at and attach to a location along the proximalsegment of each arm of the atrial set of arms that is a common distancefrom the cylindrical portion of the at least one support structure. Inalternative embodiments, the one or more covers can further extend andattach to the distal segment of each arm of the ventricular set of arms.In some embodiments, the one or more covers can extend asymmetricallyand/or non-circularly within the elongate central passageway and overone or more of the atrial set of arms and the ventricular set of arms.

In some embodiments, the atrial set of arms can be attached to theatrial end of the cylindrical portion of the at least one supportstructure, while the ventricular set of arms can be attached to theventricular end of the cylindrical portion of the at least one supportstructure. In alternative embodiments, such as the embodiment mentionedabove, the atrial set of arms can be attached to the ventricular end ofthe cylindrical portion of the at least one support structure, while theventricular set of arms can be attached to the atrial end of thecylindrical portion of the at least one support structure.

In embodiments in which the atrial set of arms is attached to theventricular end of the cylindrical portion of the at least one supportstructure, and the ventricular set of arms is attached to the atrial endof the cylindrical portion of the at least one support structure, theproximal segment of each arm of the atrial set of arms can extend fromthe ventricular end of the cylindrical portion of the at least onesupport structure toward the atrial end of the cylindrical portion ofthe at least one support structure along an exterior surface of thecylindrical portion of the at least one support structure, and thedistal segment of each arm of the atrial set of arms can extendperpendicularly away from the central axis of the elongate centralpassageway. Similarly, the proximal segment of each arm of theventricular set of arms can extend from the atrial end of thecylindrical portion of the at least one support structure toward theventricular end of the cylindrical portion of the at least one supportstructure along an exterior surface of the cylindrical portion of the atleast one support structure, and the distal segment of each arm of theventricular set of arms can extend perpendicularly away from the centralaxis of the elongate central passageway.

In further embodiments, in which the atrial set of arms is attached tothe ventricular end of the cylindrical portion of the at least onesupport structure, and the ventricular set of arms is attached to theatrial end of the cylindrical portion of the at least one supportstructure, the distal segments of the arms of the atrial set of armsthat extend perpendicularly away from the central axis of the elongatecentral passageway can extend from an atrial longitudinal position alongthe exterior surface of the cylindrical portion of the at least onesupport structure, and the distal segments of the arms of theventricular set of arms that extend perpendicularly away from thecentral axis of the elongate central passageway can extend from aventricular longitudinal position along the exterior surface of thecylindrical portion of the at least one support structure, where theatrial longitudinal position is in closer proximity to the atrial end ofthe cylindrical portion of the at least one support structure than theventricular longitudinal position is to the atrial end of thecylindrical portion of the at least one support structure.

In further embodiments in which the ventricular set of arms is attachedto the atrial end of the cylindrical portion of the at least one supportstructure, in an implanted configuration in which the at least onesupport structure biodynamically fixes the prosthetic heart valve tonative leaflets of a native heart valve, the ventricular set of arms canextend from the atrial end of the cylindrical portion of the at leastone support structure, through a native annulus of the native heartvalve, and into the ventricular side of the native heart valve tocontact the native leaflets on the ventricular side of the native heartvalve.

In further embodiments in which the atrial set of arms is attached tothe ventricular end of the cylindrical portion of the at least onesupport structure, in an implanted configuration in which the at leastone support structure biodynamically fixes the prosthetic heart valve tonative leaflets of a native heart valve, the atrial set of arms extendfrom the ventricular end of the cylindrical portion of the at least onesupport structure, through a native annulus of the native heart valve,and into the atrium of the heart to contact the native leaflets on theatrial side of the native heart valve.

These various embodiments in which the atrial set of arms is attached tothe ventricular end of the cylindrical portion of the at least onesupport structure and the ventricular set of arms is attached to theatrial end of the cylindrical portion of the at least one supportstructure serve to provide further overbite between the atrial arms andthe ventricular arms, as discussed above. Furthermore, these variousembodiments in which the atrial set of arms is attached to theventricular end of the cylindrical portion of the at least one supportstructure and the ventricular set of arms is attached to the atrial endof the cylindrical portion of the at least one support structure canenable improved distribution of forces received by the atrial andventricular arms throughout the prosthetic heart valve, thereby reducingbreakability of the prosthetic heart valve, and particularly the atrialand ventricular arms.

In certain embodiments, the cylindrical portion of the at least onesupport structure can be a cylindrical cage structure with openings. Insuch embodiments, at least some portions of the cylindrical cagestructure and the openings can be configured to receive bends of one ormore arms of the atrial set of arms and the ventricular set of armswhere the arms extend perpendicularly away from the central axis of theelongate central passageway. By configuring the cylindrical portion ofthe at least one support structure to receive bends of one or more armsof the atrial set of arms and the ventricular set of arms where the armsextend perpendicularly away from the central axis of the elongatecentral passageway, the at least one support structure can provideadditional support to the atrial set of arms and the ventricular set ofarms, and can enable improved load distribution throughout theprosthetic heart valve, thereby reducing breakability of the prostheticheart valve, and particularly the atrial and ventricular arms. Thisimproved load distribution throughout the prosthetic heart valve isparticularly important in the biodynamic prosthetic heart valvedisclosed herein, because continual biodynamic motion of the prostheticheart valve with a native heart valve during cardiac cycles of the heartcan increase load on the prosthetic heart valve and thus opportunitiesfor breakability of the prosthetic heart valve. Additionally, byproviding additional support to the atrial set of arms and theventricular set of arms, the arms can be further stabilized as they comeinto contact with native heart valve leaflets, thereby enabling axialstabilization of the prosthetic heart valve within a native heart valve.

In some embodiments, the prosthetic heart valve can include one supportstructure. However, in alternative embodiments, to further improve loaddistribution of the prosthetic heart valve, the prosthetic heart valvecan include more than one support structure. In such embodiments, theprosthetic heart valve can include two, three, or more than threesupport structures. In such multi-support structure embodiments of theprosthetic heart valve, the multiple support structures can beconfigured to fit together (e.g., to snap into place) such that one ormore of the multiple support structures receives support and loaddistribution benefits from one or more of the other multiple supportstructures, as described above. In some embodiments, to configuremultiple support structures of a prosthetic heart valve to fit together,a minimum inner diameter of the cylindrical portion of the at least onesupport structure that defines the elongate central passageway can beless than a maximum outer diameter of the elongate central passageway.In additional embodiments, a minimum diameter of a radius of curvatureof each bend of the one or more arms of the atrial set of arms and theventricular set of arms, where the arms extend perpendicularly away fromthe central axis of the elongate central passageway, can be less thanthe maximum outer diameter of the elongate central passageway.

In another aspect, the invention comprises a prosthetic heart valveincluding one or more support structures that define an elongate centralpassageway, and a valve structure attached to at least one of the one ormore support structures and disposed within the elongate centralpassageway for control of blood flow through the elongate centralpassageway. At least one of the one or more support structures includesa plurality of arms that extend away from the elongate centralpassageway for attachment of the at least one support structure tonative leaflets of a native heart valve of a heart.

In some embodiments, the plurality of arms can include an atrial set ofarms that extend from an atrial end of at least one support structurebefore curving to extend away from the elongate central passageway, anda ventricular set of arms that extend from a ventricular end of at leastone support structure before curving to extend away from the elongatecentral passageway. In some such embodiments, the atrial arms and theventricular arms can be configured to cooperate to hold the nativeleaflets of the native heart valve to maintain the elongate centralpassageway in a native annulus of the native heart valve without anydirect attachment to the native annulus or to native cords associatedwith the native heart valve.

In another aspect, the invention comprises a prosthetic heart valveincluding one or more support structures that define an elongate centralpassageway, and a plurality of leaflet elements attached to at least oneof the one or more support structures and disposed within the elongatecentral passageway. At least one of the one or more support structuresis configured to biodynamically fix the prosthetic heart valve within,and separated from, a native annulus of a native heart valve of a heart.

In some embodiments, at least one support structure of the one or moresupport structures comprises a cylindrical portion comprising an atrialend and a ventricular end. The elongate central passageway can bedefined by the cylindrical portion of the at least one supportstructure. Additionally, the cylindrical portion of the at least onesupport structure can be expandable to a maximum radial width that isless than a minimum radial width of the native annulus of the nativeheart valve.

In some embodiments, to biodynamically fix the prosthetic heart valvewithin, and separated from, the native annulus of the native heartvalve, at least one of the one or more support structures of theprosthetic heart valve is configured to grasp native leaflets of thenative heart valve, without direct attachment to the native annulus ornative cords associated with the native heart valve.

In some embodiments, the native heart valve can be the tricuspid heartvalve.

In another aspect, the invention comprises a method of transcatheterimplantation of a prosthetic heart valve. The prosthetic heart valveincludes at least one support structure having a cylindrical portion.The cylindrical portion of the at least one support structure defines anelongate central passageway of the prosthetic heart valve. Theprosthetic heart valve also includes an atrial plurality of armsextending from a ventricular end of the cylindrical portion of the atleast one support structure. Each arm of the atrial plurality of armsincludes a proximal segment that is proximal to the cylindrical portionof the at least one support structure, and a distal segment that isdistal to the cylindrical portion of the at least one support structure.The prosthetic heart valve also includes a ventricular plurality of armsextending from an atrial end of the cylindrical portion of the at leastone support structure. Each arm of the ventricular plurality of armsincludes a proximal segment that is proximal to the cylindrical portionof the at least one support structure, and a distal segment that isdistal to the cylindrical portion of the at least one support structure.

The method of transcatheter implantation of the prosthetic heart valveincludes guiding the prosthetic heart valve into a native valve of aheart of a patient via a vein of the patient while the prosthetic heartvalve is in a contracted configuration in which the elongate centralpassageway has an atrial diameter, each arm of the ventricular pluralityof arms is held against an exterior surface of the cylindrical portionof the at least one support structure by a sheath, and each arm of theatrial plurality of arms is held within the sheath and against theexterior surface of the cylindrical portion of the at least one supportstructure by a respective restraint of a plurality of restraints. Themethod further includes retracting the sheath to allow each arm of theventricular plurality of arms to bend such that a distal segment of eacharm of the ventricular plurality of arms extends away from thecylindrical portion of the at least one support structure. The methodfurther includes retracting the prosthetic heart valve along with thesheath until the distal segment of each arm of the ventricular pluralityof arms contacts native leaflets of the native heart valve on aventricular side of the native heart valve. The method further includesexpanding the cylindrical portion of the at least one support structurefrom the contracted configuration with the atrial diameter to anexpanded configuration with a larger ventricular diameter to form theelongate central passageway. The method further includes advancing theplurality of restraints to allow each arm of the atrial plurality ofarms to bend such that a distal segment of each arm of the atrialplurality of arms extends away from the cylindrical portion of the atleast one support structure and captures the native leaflets of thenative heart valve on an atrial side of the native heart valve againstthe distal segment of the ventricular plurality of arms contacting thenative leaflets of the native heart valve on the ventricular side of thenative heart valve.

In some embodiments, retracting the sheath to allow each arm of theventricular plurality of arms to bend such that the distal segment ofeach arm of the ventricular plurality of arms extends away from thecylindrical portion of the at least one support structure furtherincludes allowing each arm of the ventricular plurality of arms to bendsuch that the proximal segment of each arm of the ventricular pluralityof arms extends along the exterior surface of the cylindrical portion ofthe at least one support structure. Additionally, in such embodiments,advancing the plurality of restraints to allow each arm of the atrialplurality of arms to bend such that the distal segment of each arm ofthe atrial plurality of arms extends away from the cylindrical portionof the at least one support structure can further include allowing eacharm of the atrial plurality of arms to bend such that the proximalsegment of each arm of the atrial plurality of arms extends along theexterior surface of the cylindrical portion of the at least one supportstructure.

In some embodiments, the method can further include detaching theplurality of restraints from the atrial plurality of arms.

In some embodiments, the method can further include repositioning theprosthetic heart valve within the native heart valve by retracting theplurality of restraints from the atrial plurality of arms to straighteneach arm of the atrial plurality of arms against the exterior surface ofthe cylindrical portion of the at least one support structure to releasethe native leaflets of the native heart valve, while pushing the atleast one support structure toward the ventricular side of the nativeheart valve with a plurality of spreader arms.

In some embodiments, the method can further include re-capturing andremoving the prosthetic heart valve from the native heart valve byadvancing the sheath to straighten each arm of the ventricular pluralityof arms and compress the cylindrical portion of the at least one supportstructure for removal of the prosthetic heart valve from the nativeheart valve via the vein of the patient while the prosthetic heart valveis in a contracted configuration.

In some embodiments, advancing the plurality of restraints can includeadvancing the restraints while maintaining contact with the at least onesupport structure with a plurality of spreader arms.

In some embodiments, the plurality of spreader arms can extend from amid layer within the sheath. In certain embodiments, each restraint ofthe plurality of restraints can extend from the sheath between a pair ofthe plurality of spreader arms. In certain embodiments, each spreaderarm of the plurality of spreader arms can include an interlockingmechanism that maintains contact with the atrial end of the cylindricalportion of the at least one support structure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate disclosed embodiments and together with thedescription serve to explain the principles of the disclosedembodiments. In the drawings:

FIG. 1 is a schematic perspective view of a support structure for aprosthetic heart valve, in accordance with an embodiment.

FIG. 2 is a schematic cross-sectional perspective view of a prostheticheart valve, in accordance with an embodiment.

FIG. 3 is another schematic cross-sectional perspective view of aprosthetic heart valve, in accordance with an embodiment.

FIGS. 4-8 illustrate a prosthetic heart valve in various stages ofimplantation, in accordance with an embodiment.

FIGS. 9-12 illustrate a prosthetic heart valve in various stages ofremoval, in accordance with an embodiment.

FIG. 13 illustrates a top view of a prosthetic heart valve, inaccordance with an embodiment.

FIG. 14 illustrates various implantation routes for a prosthetic heartvalve, in accordance with an embodiment.

FIGS. 15 and 16 illustrate a portion of support structure for aprosthetic heart valve, in accordance with an embodiment.

FIG. 17 is another schematic cross-sectional perspective view of aprosthetic heart valve, in accordance with an embodiment.

FIG. 18 is another schematic cross-sectional perspective view of aprosthetic heart valve, in accordance with an embodiment.

FIG. 19 illustrates another example support structure for a prostheticheart valve, in accordance with an embodiment.

FIG. 20 illustrates various forces that can be applied duringimplantation of a prosthetic heart valve, in accordance with anembodiment.

FIGS. 21 and 22 illustrate various implementations of a portion of asupport structure for a prosthetic heart valve, in accordance with anembodiment.

FIG. 23 illustrates various delivery structures for a prosthetic heartvalve, in accordance with an embodiment.

FIG. 24 illustrates a side view of a pair of arms extending from acylindrical portion of a support structure of a prosthetic heart valve,in accordance with an embodiment.

FIGS. 25 and 26 illustrate various views of a nose cone and guidewirefor implantation of a prosthetic heart valve, in accordance with anembodiment.

FIGS. 27-30 illustrate various aspects of a prosthetic heart valvehaving another support structure, in accordance with an embodiment.

FIGS. 31-34 illustrate various other aspects of prosthetic heart valvesthat are contemplated herein, in accordance with an embodiment.

FIG. 35 illustrates a perspective view of the support structure for theprosthetic heart valve interfacing with a delivery system, in accordancewith an embodiment.

FIG. 36 illustrates a perspective view of the spreader arms of FIG. 35in accordance with various aspects of the subject technology, inaccordance with an embodiment.

FIG. 37 illustrates a wider perspective view of the support structurefor the prosthetic heart valve interfacing with a delivery system inaccordance with various aspects of the subject technology, in accordancewith an embodiment.

FIG. 38 illustrates a perspective view of a portion of a mid layer of adelivery system for a prosthetic heart valve, in accordance with anembodiment.

FIG. 39 illustrates a perspective view of a prosthetic heart valveinterfacing with a delivery system, in accordance with an embodiment.

FIG. 40 illustrates a partially transparent perspective view of thesupport structure for the prosthetic heart valve interfacing with thedelivery system, in accordance with an embodiment.

FIG. 41 illustrates a perspective view of a support structure for aprosthetic heart valve prior to formation of bends in arms that extendfrom a cylindrical portion, in accordance with an embodiment.

FIG. 42A illustrates a prosthetic tricuspid valve implanted in a nativetricuspid valve of a heart during diastolic filling of a ventricle ofthe heart, in accordance with an embodiment.

FIG. 42B illustrates a prosthetic tricuspid valve implanted in a nativetricuspid valve of a heart during systolic contraction of a ventricle ofthe heart, in accordance with an embodiment.

FIG. 43A illustrates another implementation of a support structure for aprosthetic tricuspid valve in a contracted configuration, and definingan elongate central passageway having a first diameter, in accordancewith an embodiment.

FIG. 43B illustrates another implementation of a support structure for aprosthetic tricuspid valve in an expanded configuration, and defining anelongate central passageway having a second diameter that is larger thanthe first diameter, in accordance with an embodiment.

FIG. 44A illustrates a view of a flattened support structure of aprosthetic tricuspid valve having one support structure, in accordancewith an embodiment.

FIG. 44B illustrates a side view of a prosthetic tricuspid valve havingone support structure and configured for implantation in a nativetricuspid valve, in accordance with an embodiment.

FIG. 45A illustrates a CAD drawing of a side view of a prosthetictricuspid valve having one support structure, in accordance with anembodiment.

FIG. 45B illustrates a CAD drawing of a top-down view of a prosthetictricuspid valve having one support structure, in accordance with anembodiment.

FIG. 45C illustrates a CAD drawing of a titled side view of a prosthetictricuspid valve having one support structure, in accordance with anembodiment.

FIG. 45D illustrates a CAD drawing of a side view of a prosthetictricuspid valve having one support structure, in accordance with anembodiment.

FIG. 46A illustrates a view of flattened support structures and of aprosthetic tricuspid valve having two support structures, in accordancewith an embodiment.

FIG. 46B illustrates a side view of a prosthetic tricuspid valve havingtwo support structures, and configured for implantation in a nativetricuspid valve, in accordance with an embodiment.

FIG. 47A illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having two support structures,in accordance with an embodiment.

FIG. 47B illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having two support structures,in accordance with an embodiment.

FIG. 47C illustrates a CAD drawing of a side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 47D illustrates a CAD drawing of a top-down view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 47E illustrates a CAD drawing of a tilted side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 47F illustrates a CAD drawing of another side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 48A illustrates a view of flattened support structures of aprosthetic tricuspid valve having two support structures, in accordancewith an embodiment.

FIG. 48B illustrates a side view of a prosthetic tricuspid valve havingtwo support structures and configured for implantation in a nativetricuspid valve, in accordance with an embodiment.

FIG. 49A illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having two support structures,in accordance with an embodiment.

FIG. 49B illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having two support structures,in accordance with an embodiment.

FIG. 49C illustrates a CAD drawing of a side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 49D illustrates a CAD drawing of a top-down view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 49E illustrates a CAD drawing of a tilted side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 49F illustrates a CAD drawing of another side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 50A illustrates a view of flattened support structures of aprosthetic tricuspid valve having two support structures, in accordancewith an embodiment.

FIG. 50B illustrates a side view of a prosthetic tricuspid valve havingtwo support structures and configured for implantation in a nativetricuspid valve, in accordance with an embodiment.

FIG. 51A illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having two support structures,in accordance with an embodiment.

FIG. 51B illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having two support structures,in accordance with an embodiment.

FIG. 51C illustrates a CAD drawing of a side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 51D illustrates a CAD drawing of a top-down view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 51E illustrates a CAD drawing of a tilted side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 51F illustrates a CAD drawing of another side view of a prosthetictricuspid valve having two support structures, in accordance with anembodiment.

FIG. 52A illustrates a view of flattened support structures of aprosthetic tricuspid valve having three support structures, inaccordance with an embodiment.

FIG. 52B illustrates a side view of a prosthetic tricuspid valve havingthree support structures and configured for implantation in a nativetricuspid valve, in accordance with an embodiment.

FIG. 53A illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having three supportstructures, in accordance with an embodiment.

FIG. 53B illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having three supportstructures, in accordance with an embodiment.

FIG. 53C illustrates a CAD drawing of a tilted side view of a supportstructure of a prosthetic tricuspid valve having three supportstructures, in accordance with an embodiment.

FIG. 53D illustrates a CAD drawing of a side view of a prosthetictricuspid valve having three support structures, in accordance with anembodiment.

FIG. 53E illustrates a CAD drawing of a top-down view of a prosthetictricuspid valve having three support structures, in accordance with anembodiment.

FIG. 53F illustrates a CAD drawing of a tilted side view of a prosthetictricuspid valve having three support structures, in accordance with anembodiment.

FIG. 53G illustrates a CAD drawing of another side view of a prosthetictricuspid valve having three support structures, in accordance with anembodiment.

FIG. 54A illustrates a side view of overbite between an atrial arm and aventricular arm of a prosthetic tricuspid valve at rest, in accordancewith an embodiment.

FIG. 54B illustrates a side view of an atrial arm and a ventricular armof a prosthetic tricuspid valve when a prosthetic tricuspid valve isimplanted in a native tricuspid valve, in accordance with an embodiment.

FIG. 55 illustrates a CAD drawing of a cut-away side view of aprosthetic tricuspid valve having three support structures, inaccordance with an embodiment.

FIG. 56A is a top-down view of an image of a prototype prosthetictricuspid valve clamping onto a sheet of paper oriented approximatelyperpendicular (e.g., 90° +/−45°) to the central axis of an elongatecentral passageway of the prosthetic tricuspid valve, in accordance withan embodiment.

FIG. 56B is a bottom-up view of an image of a prototype prosthetictricuspid valve clamping onto a sheet of paper oriented approximatelyperpendicular (e.g., 90° +/−45°) to the central axis of the elongatecentral passageway of the prosthetic tricuspid valve, in accordance withan embodiment.

FIG. 56C is a side view of an image of a prototype prosthetic tricuspidvalve clamping onto a sheet of paper oriented approximatelyperpendicular (e.g., 90° +/−45°) to the central axis of the elongatecentral passageway of the prosthetic tricuspid valve, in accordance withan embodiment.

FIG. 57 is a bottom-up view of an image of a prototype prosthetictricuspid valve, in accordance with an embodiment.

FIG. 58 illustrates a CAD drawing of a tilted side view of a prosthetictricuspid valve having three support structures, in accordance with anembodiment.

FIG. 59 illustrates a view of a flattened support structure of aprosthetic tricuspid valve, in accordance with an embodiment.

FIG. 60 illustrates loading, locking, and releasing of interlockingmechanisms of a support structure of a prosthetic tricuspid valve, inaccordance with an embodiment.

FIG. 61 illustrates a view of a flattened support structure configuredto form ventricular arms of a prosthetic tricuspid valve, in accordancewith an embodiment.

FIG. 62A is an image of a prototype support structure formingventricular arms of a prosthetic tricuspid valve, in accordance with anembodiment.

FIG. 62B is an image of a prototype support structure formingventricular arms and ventricular-directed arms of a prosthetic tricuspidvalve, in accordance with an embodiment.

FIG. 63A illustrates a top-down view of a CAD drawing of a supportstructure forming ventricular arms of a prosthetic tricuspid valve, inaccordance with an embodiment.

FIG. 63B illustrates a side view of a CAD drawing of a support structureforming ventricular arms of a prosthetic tricuspid valve, in accordancewith an embodiment.

FIG. 64A illustrates a top-down view of a CAD drawing of a supportstructure forming ventricular arms and ventricular-directed arms of aprosthetic tricuspid valve, in accordance with an embodiment.

FIG. 64B illustrates a side view of a CAD drawing of a support structureforming ventricular arms and ventricular-directed arms of a prosthetictricuspid valve, in accordance with an embodiment.

FIG. 65 illustrates a view of a flattened support structure configuredto form atrial arms of a prosthetic tricuspid valve, in accordance withan embodiment.

FIG. 66 illustrates a CAD drawing of a side view of a prosthetictricuspid valve, in accordance with an embodiment.

FIG. 67A illustrates a side view of a relatively small amount ofoverbite between an atrial arm and a ventricular arm of a prosthetictricuspid valve, in accordance with an embodiment.

FIG. 67B illustrates a side view of a relatively moderate amount ofoverbite between an atrial arm and a ventricular arm of a prosthetictricuspid valve, in accordance with an embodiment.

FIG. 67C illustrates a side view of a relatively large amount ofoverbite between an atrial arm and a ventricular arm of a prosthetictricuspid valve, in accordance with an embodiment.

FIG. 68A illustrates a symmetric implementation of an atrial sealingskirt, in accordance with an embodiment.

FIG. 68B illustrates an asymmetric implementation of an atrial sealingskirt, in accordance with an embodiment.

FIG. 69A is an image of a bottom-up view of support structures of aprototype prosthetic tricuspid valve, in accordance with an embodiment.

FIG. 69B is an image of a side view of support structures of a prototypeprosthetic tricuspid valve, in accordance with an embodiment.

FIG. 70A is an image of a bottom-up view of support structures of aprototype prosthetic tricuspid valve, in accordance with an embodiment.

FIG. 70B is an image of a side view of support structures of a prototypeprosthetic tricuspid valve, in accordance with an embodiment.

FIG. 71 is an image of a top-down view of a support structure of aprototype prosthetic tricuspid valve, in accordance with an embodiment.

FIG. 72A is an image of a top-down view of support structures of aprototype prosthetic tricuspid valve, in accordance with an embodiment.

FIG. 72B is an image of a side view of support structures of a prototypeprosthetic tricuspid valve, in accordance with an embodiment.

FIG. 73 illustrates an atrial sealing skirt including a ventricular armsleeve configured to encapsulate a ventricular arm of a supportstructure, in accordance with an embodiment.

FIG. 74 is an image of a side view of a prototype prosthetic tricuspidvalve, in accordance with an embodiment.

FIG. 75 illustrates load distribution for a prosthetic tricuspid valvehaving one support structure, in accordance with an embodiment.

FIG. 76 illustrates load distribution for a prosthetic tricuspid valvehaving two support structures, in accordance with an embodiment.

FIG. 77 illustrates load distribution for a prosthetic tricuspid valvehaving two support structures, in accordance with an embodiment.

FIG. 78 illustrates load distribution for a prosthetic tricuspid valvehaving two support structures, in accordance with an embodiment.

FIG. 79 illustrates load distribution for a prosthetic tricuspid valvehaving three support structures, in accordance with an embodiment.

FIG. 80 illustrates a CAD drawing of a cut-away side view of aprosthetic tricuspid valve, in accordance with an embodiment.

DETAILED DESCRIPTION

The detailed description set forth below describes variousconfigurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The detailed description includes specific details for thepurpose of providing a thorough understanding of the subject technology.Accordingly, dimensions may be provided in regard to certain aspects asnon-limiting examples. However, it will be apparent to those skilled inthe art that the subject technology may be practiced without thesespecific details. In some instances, well-known structures andcomponents are shown in block diagram form in order to avoid obscuringthe concepts of the subject technology.

It is to be understood that the present disclosure includes examples ofthe subject technology and does not limit the scope of the appendedclaims. Various aspects of the subject technology will now be disclosedaccording to particular but non-limiting examples. Various embodimentsdescribed in the present disclosure may be carried out in different waysand variations, and in accordance with a desired application orimplementation.

In the following detailed description, numerous specific details are setforth to provide a full understanding of the present disclosure. It willbe apparent, however, to one ordinarily skilled in the art thatembodiments of the present disclosure may be practiced without some ofthe specific details. In other instances, well-known structures andtechniques have not been shown in detail so as not to obscure thedisclosure.

Because aortic and mitral valve replacements have generally been thefocus of device development, the need for a solution for TricuspidRegurgitation (TR) remains unaddressed, particularly because there isgrowing evidence showing that TR is associated with higher mortalityrates and should not be left untreated even if the other heart valveshave been addressed.

Like the mitral valve, the tricuspid valve is in an atrio-ventricularposition. Consequently, it might be expected that a mitral valvereplacement could be repurposed for use in the tricuspid position.However, specific aspects of the tricuspid valve anatomy and thesurrounding anatomy (e.g. the tricuspid valve's larger size andproximity to conductive regions of the heart) make a dedicated solutionmore favorable than such a repurposing of mitral valve devices.

In accordance with aspects of the disclosure, a biodynamic prosthetictricuspid valve is provided herein. As mentioned above, as referred toherein, the term “biodynamic” with regard to a prosthetic tricuspidvalve, refers to a configuration of the prosthetic tricuspid valve thatallows the prosthetic tricuspid valve to maintain axial stabilizationwithin a native tricuspid valve of a heart, but to move within thenative tricuspid valve responsive to alternating pressure differentialson either side of the native tricuspid valve during cardiac cycles ofthe heart, without directly attaching to a native annulus or nativechords of the native tricuspid valve, thereby preserving the naturalmotion of the native annulus. Specifically, the prosthetic tricuspidvalve is axially stabilized within the native tricuspid valve bygrasping the native leaflets of the native tricuspid valve, rather thanrelying on annular force or direct annular or chordal attachment. Asreferred to herein, the term “axial stabilization” with regard to aprosthetic tricuspid valve located within a native tricuspid valverefers to a portion of the prosthetic tricuspid valve being interposedbetween any two diametrically opposed points on a native annulus of thenative tricuspid valve.

The prosthetic tricuspid valve includes one or more support structures.For example, as discussed in further detail below, the prosthetictricuspid valve can include one, two, three, or more than three supportstructures. At least one of the one or more support structures includesa cylindrical portion having an atrial end and a ventricular end. Thecylindrical portion of the at least one support structure defines anelongate central passageway of the prosthetic tricuspid valve. A centralaxis of the elongate central passageway extends within the elongatecentral passageway from the atrial end of the cylindrical portion to theventricular end of the cylindrical portion. When the prosthetictricuspid valve is in an implanted configuration in a native tricuspidvalve of a heart, blood flows through the elongate central passageway ofthe prosthetic tricuspid valve from an atrium of the heart to aventricle of the heart, along the central axis of the elongate centralpassageway. Furthermore, a plurality of leaflet elements attach to theat least one support structure and are disposed within the elongatecentral passageway for control of blood flow through the elongatecentral passageway.

Ventricular arms extending from a first end of the cylindrical portionof the at least one support structure extend into the ventricle of theheart to contact the ventricular surface of the native leaflets, whileatrial arms extending from a second end opposite the first end of thecylindrical portion of the at least one support structure extend intothe atrium to contact the atrial surface of the native leaflets. Variousfeatures of the prosthetic tricuspid valve configure the valve fortranscatheter implantation, re-positioning, and/or removal. Theprosthetic tricuspid valve described herein can be easily positioned anddeployed in a wide range of patients with the ability to control thedeployment, assess complete functionality, and maintain the ability torecapture and remove the implant prior to full release.

Although various examples are described herein in which prosthetictricuspid valves are configured for replacement of the native tricuspidvalve, it should be appreciated that appropriate modifications can bemade for use of the prosthetic tricuspid valves disclosed herein toreplace other native heart valves and/or in any other non-heart valves.

FIG. 1 illustrates an example prosthetic tricuspid valve 100 inaccordance with aspects of the disclosure. In the example of FIG. 1,prosthetic tricuspid valve 100 includes a support structure 102 having acylindrical portion 116 that defines an elongate central passageway 104.Cylindrical portion 116 has an atrial end 118 configured to be disposedin the atrium of the heart, and a ventricular end 120 configured to bedisposed in the ventricle of the heart. A central axis of the elongatecentral passageway 104 along which blood flows from the atrium of theheart to the ventricle of the heart is depicted in FIG. 1 by a dottedline.

Although cylindrical portion 116 is shown as a solid cylindricalstructure, it should be appreciated that the cylindrical portion 116 canbe formed from other structures such as, for example, a radiallyexpandable and compactable cylindrical cage structure with openings thatcan be balloon expandable or self-expanding. In such embodiments, thecylindrical cage structure can be made of laser cut metal, polymertubing, and/or wire-formed material. In this example, some of theopenings (not shown in FIG. 1, see FIG. 15, 16, 21 or 22) may bepositioned to receive one or more bends of one or more of arms 106described below, to maintain uniformity and symmetry during loading andrecapturing of the prosthetic tricuspid valve 100, and/or to enable loaddistribution from the one or more arms 106 throughout the supportstructure 102 of the prosthetic tricuspid valve 100. In variousstructural implementations, cylindrical portion 116 is radiallycollapsible (e.g., into elongate central passageway 104) fortranscatheter implantation.

Cylindrical portion 116 is undersized relative to a native tricuspidvalve annulus so as not to put any radial force on the annulus.Specifically, in the example of FIG. 1 and various other examplesdescribed herein, cylindrical portion 116 is expandable to a maximumradial width that is less than the minimum radial width of the nativeannulus of the native tricuspid valve. As described in detail below, thearms 106 are configured to cooperate to hold the native leaflets of thenative tricuspid valve to maintain the elongate central passageway 104in the native annulus of the native tricuspid valve without any directattachment to the native annulus or cords so that prosthetic tricuspidvalve 100 is biodynamically fixed within, and separated from, the nativeannulus of the native tricuspid valve. However, it should be appreciatedthat some portions of the prosthetic tricuspid valve 100 can extend toor beyond the native annulus. For example, and as discussed in furtherdetail hereinafter, the prosthetic tricuspid valve 100 may include anatrial sealing skirt that extends to or beyond the native annulus foranchoring and/or to fully cover the commissures of the native tricuspidvalve for leak prevention.

Cylindrical portion 116 is depicted in FIG. 1 as having a circular crosssection, but it should be appreciated that cylindrical portion 116 canhave a generally cylindrical shape without a perfectly circular crosssection. For example, cylindrical portion 116 can have a cross sectionthat is circular or non-circular (e.g. D-shaped, triangular, oval, orany other cross-sectional geometry), and can be configured such that oneprosthetic tricuspid valve size accommodates all patients (e.g., withdifferent sizing only for the arms 106 and an atrial sealing skirt to bedescribed hereinafter) or with a range of prosthetic tricuspid valvesizes depending on patient anatomy.

Although not shown in FIG. 1, a plurality of leaflet elements can beattached to support structure 102 and disposed within the elongatecentral passageway 104 for control of blood flow through the elongatecentral passageway. These leaflet elements replace the function of thenative leaflets once the prosthetic tricuspid valve 100 is installed.

As shown in FIG. 1, the prosthetic tricuspid valve 100 is biodynamicallyfixed within, and separated from, a native annulus of a native tricuspidvalve by fixing the prosthetic tricuspid valve 100 to native leaflets ofthe native tricuspid valve using a plurality of ventricular arms 106-1and atrial arms 106-2. Specifically, the plurality of ventricular arms106-1 extend from a first end of the cylindrical portion 116 of thesupport structure 102 and contact a ventricular side of the nativeleaflets of the native tricuspid valve. Similarly, the plurality ofatrial arms 106-2 extend from a second end opposite the first end of thecylindrical portion 116 of the support structure 102 and contact anatrial side of the native leaflets of the native tricuspid valve. Asshown in FIG. 1, the atrial arms 106-1 may alternate with theventricular arms 106-2 around a circumference of the cylindrical portion116 of the support structure 102.

Each arm 106 comprises a proximal segment and a distal segment. Theproximal segment of each arm 106 is proximal to the cylindrical portion116 of the support structure 102. Specifically, the proximal segment ofeach arm 106 is the segment of the arm 106 that is attached to thecylindrical portion 116 of the support structure 102. The proximalsegment of each arm 106 extends from its attachment point at thecylindrical portion 116 along an exterior surface 147 of the cylindricalportion 116, and ends at (and includes) a secondary bend that directsthe distal segment of the arm away from and perpendicular to the centralaxis of the elongate central passageway 104. The secondary bend directsthe distal segment of the arm away from and perpendicular to the centralaxis of the elongate central passageway 104 at a longitudinal positionalong the exterior surface 147 of the cylindrical portion 116. In someembodiments (e.g., the embodiment of the prosthetic tricuspid device 100in FIG. 1), the proximal segment of each arm 106 also includes aninitial bend that directs the proximal segment of the arm 106 along theexterior surface 147 of the cylindrical portion 116.

Each atrial arm 106-1 has a proximal segment 112 and each ventriculararm 106-2 has a proximal segment 108. As shown in FIG. 1 and asdiscussed in further detail below, the optional initial bend of theproximal segment 112 of each atrial arm 106-1 is an initial bend 128,and the secondary bend of the proximal segment 112 of each atrial arm106-1 is a secondary bend 130. Similarly, the optional initial bend ofthe proximal segment 108 of each ventricular arm 106-2 is an initialbend 124, and the secondary bend of the proximal segment 108 of eachventricular arm 106-2 is a secondary bend 126.

The distal segment of each arm 106 is distal to the cylindrical portion116 of the at least one support structure 102. Specifically, the distalsegment of each arm 106 is the segment of the arm 106 that contacts anobject (e.g., the native leaflets of the native tricuspid valve). Thedistal segment of an arm 106 contacts an object (e.g., the nativeleaflets of the native tricuspid valve) at a point of contact along thedistal segment of the arm 106. The distal segment of each arm 106extends from (and does not include) the secondary bend of the arm 106,extends away from and perpendicular to the central axis of the elongatecentral passageway 104, and ends at (and includes) a tip. As mentionedabove, the distal segment of the arm extends away from and perpendicularto the central axis of the elongate central passageway 104 from alongitudinal position along the exterior surface 147 of the cylindricalportion 116.

In some embodiments discussed in detail below with regard to FIG. 24,the distal segment of each arm can include an extended segment having athird bend. Each atrial arm 106-1 has a distal segment 114 and eachventricular arm 106-2 has a distal segment 110. As discussed in furtherdetail below, the tip of the distal segment 114 of each atrial arm 106-1is a tip 142, and the tip of the distal segment 110 of each ventriculararm 106-2 is a tip 140.

In the example of FIG. 1, the proximal segment 108 of each ventriculararm 106-2 extends from the atrial end 118 of cylindrical portion 116 andhas the initial bend 124 of 180° +/−45° that directs the proximalsegment 108 of the ventricular arm 106-2 along the exterior surface 147of cylindrical portion 116, through the native annulus (outside of theelongate central passageway 104), and sufficiently towards theventricular end 120. Then, following the secondary bend 126 in theproximal segment 108 of the ventricular arm 106-2, the distal segment110 of the ventricular arm 106-2 extends away from and perpendicular tothe central axis of the elongate central passageway 104, from alongitudinal position along the exterior surface 147 of the cylindricalportion 116.

FIG. 1 also shows how the proximal segment 112 of each atrial arm 106-1extends from the ventricular end 120 of cylindrical portion 116 and hasthe initial bend 128 of 180° +/−45° that directs the proximal segment112 of the atrial arm 106-1 along the exterior surface 147 ofcylindrical portion 116, through the native annulus (outside of theelongate central passageway 104), and sufficiently towards the atrialend 118 of the cylindrical portion 116. Then, following the secondarybend 130 in the proximal segment 112 of the atrial arm 106-1, the distalsegment 114 of the atrial arm 106-1 extends away from and perpendicularto the central axis of the elongate central passageway 104, from alongitudinal position along the exterior surface 147 of the cylindricalportion 116. As mentioned above, in some embodiments, the proximalsegments of one or more arms 106 do not include an initial bend.

As mentioned above, the distal segment of each arm 106 extendsperpendicularly away from the central axis of the elongate centralpassageway 104 for attachment of the support structure 102 to the nativeleaflets of the native tricuspid valve. As referred to herein, a distalsegment of an arm 106 extending “perpendicularly” away from the centralaxis of the elongate central passageway 104 refers to the distal segmentof the arm 160 extending away from the central axis of the elongatecentral passageway 104 such that that a line drawn from a point ofcontact of the distal segment with an object (e.g., a native tricuspidvalve leaflet) to a longitudinal position along the exterior surface 147of the cylindrical portion 116 of the at least one support structure 102from which the distal segment extends, is oriented approximately 90°+/−45° from the central axis of the elongate central passageway 104. Insome embodiments, the point of contact of a distal segment of an arm 106can be the tip 140 or 142 of the arm 106. In alternative embodiments inwhich a distal segment of an arm 106 includes an extended segment havinga third bend, the points of contact of the distal segment of the arm canbe the extended segment, or more particularly, the third bend, of thearm 106. The point of contact of a distal segment of an arm 106 can alsobe any other portion of the distal segment of the arm 106. As discussedin further detail below, this approximate perpendicularity of the linefrom the point of contact of the distal segment to the longitudinalposition along the exterior surface 147 of the cylindrical portion 116from which the distal segment extends enables axial stabilization of theprosthetic tricuspid valve within the native tricuspid valve.

The distal segment 114 of each atrial arm 106-1 and the distal segment110 of each ventricular arm 106-2 that extend perpendicularly away fromthe central axis of the elongate central passageway 104 are resilientlystraightenable (e.g., against the exterior surface 147 of cylindricalportion 116 of the support structure 102) with or without extendingbeyond the length of the cylindrical portion 116. In this way,prosthetic tricuspid valve 100 is configured to have a reduced length tofacilitate navigation of curves or bends along an insertion pathway(e.g., within the vasculature (e.g., vein or artery) of the patient andinto the heart).

In the example of FIG. 1, the ventricular arms 106-2 extend from theatrial end 118 of the cylindrical portion 116, the atrial arms 106-1extend from the ventricular end 120 of the cylindrical portion 116, andrelative locations of the secondary bends 126 and 130 are such that thelocation of the secondary bend 126 of each ventricular arm 106-2 iscloser in proximity to the ventricular end 120 of the cylindricalportion 116 than the secondary bend 130 of each atrial arm 106-1. Inother words, in the example of FIG. 1, the atrial arms 106-1 and theventricular arms 106-2 extend across a cross-sectional plane of thecylindrical portion 116 of the at least one support structure 102 suchthat there is overbite between the atrial arms 106-1 and the ventriculararms 106-2 over the cross-sectional plane. As referred to herein, a“cross-sectional plane” with regard to a cylindrical portion of at leastone support structure is a cross-sectional plane of the cylindricalportion of the at least one support structure that is perpendicular to acentral axis of a elongate central passageway defined by the cylindricalportion of the at least one support structure. As a result of thisoverbite between the atrial arms 106-1 and the ventricular arms 106-2,in vivo, the ventricular arms 106-2 extending from the atrial end 118 ofthe cylindrical portion 116 extend down into the ventricle of the heartto contact the ventricular surface of the native leaflets, while theatrial arms 106-1 extending from the ventricular end 120 of thecylindrical portion 116 extend up into the atrium of the heart tocontact the atrial surface of the native leaflets.

Additionally, in some embodiments, the relative bend angle of thesecondary bends 126 and 130 can each or either be slightly greater than90° , such that the tip 140 of each ventricular arm 106-2 is closer inproximity to the atrial end 118 of the cylindrical portion 116 than thetip 142 of each atrial arm 106-1. This arrangement further contributesto the overbite of the atrial arms 106-1 and the ventricular arms 106-2described above. Upon implantation, this overbite of the atrial arms106-1 and the ventricular arms 106-2 will result in additional clampingaction and further tensioning of the native leaflets because the distalsegments 114 of the atrial arms 106-1 on the atrial side of the nativeleaflets will be actively pushing down towards the ventricle of theheart, while the distal segments 110 of the ventricular arms 106-2 onthe ventricular side of the native leaflets will be actively pushing uptowards the atrium of the heart, thereby effectively creating acorrugated effect in the native leaflets like a ruffled collar. Thistensioning effect from the opposing forces on either side of the nativeleaflets will help to axially stabilize the prosthetic tricuspid valve100 within the native tricuspid valve.

Securing prosthetic tricuspid valve 100 to either side of the nativeleaflets in this way also creates a trampoline effect where ventricularsystolic pressure load can be partially absorbed by the upward (atrial)motion and tensioning of the native leaflets. Specifically, in thisexample, the arms 106 are bent such that, in the event of motion of thecylindrical portion 116 of the support structure 102 toward the atrialside 118 of the native tricuspid valve (e.g., due to a ventricularsystolic pressure load), the ventricular arms 106-2 resist the motionwhile the atrial arms 106-1 relax to maintain contact with the atrialside of the native leaflets. Additionally, in the event of motion of thecylindrical portion 116 of the support structure 102 toward theventricular side 120 of the native tricuspid valve, the atrial arms106-1 resist the motion while the ventricular arms 106-2 relax tomaintain contact with the ventricular side of the native leaflets.Furthermore, as a result of the trampoline effect, force from the distalsegment 110 of each ventricular arm 106-2 against the ventricular sideof the native leaflets can be further distributed throughout an atrialsealing skirt to minimize the risk of erosion through the nativeleaflets. In this way, the prosthetic tricuspid valve 100 isbiodynamically fixed within the native tricuspid valve during thecardiac cycle.

It should be appreciated that, although tips 140 and 142 of arms 106-2and 106-1 are depicted in FIG. 1 as having a square cross-section, inother implementations the cross-sectional configuration of the tips 140and 142 of arms 106-2 and 106-1 can have a circular or anothernon-circular shape (e.g., in order to provide improved attachment and/orleak prevention such as in the presence of an atrial sealing skirt asdiscussed in further detail hereinafter). The relative lengths of thedistal segments 114 of the atrial arms 106-1 and/or the distal segments110 of the ventricular arms 106-2 can also be modified for improvedattachment and/or leak prevention.

FIG. 2 shows an example of a cover 200 that can be provided over supportstructure 102. Cover 200 can be made from bioprosthetic tissue (e.g.bovine, porcine, etc.) or can be made from synthetic material (e.g.polyurethane, ePTFE, proprietary hydrogel materials, etc.). As shown,cover 200 can include a cylindrical portion 202 that defines theelongate central passageway 104 and to which prosthetic leaflet elements(not shown) can be attached. Cover 200 can also include an atrialsealing skirt 204 that extends over the atrial end 118 of supportstructure 102 and at least partially over the atrial arms 106-1.

The atrial sealing skirt 204 may also facilitate the recapturable natureof the prosthetic tricuspid valve 100. For example, reduction of theatrial arm 106-1 length while maintaining contact with the atrial end118 of the cylindrical portion 116 of the support structure 102, mayfold up the atrial sealing skirt 204 and then allow for an outer sheath(see 406 of FIG. 4) to be advanced toward the ventricular side of thenative tricuspid valve, in order to recapture the ventricular arms 106-2contacting the ventricular side of the native leaflets of the nativetricuspid valve, and fully reposition or remove the implant prior tofinal release.

In these examples, a portion of the atrial sealing skirt 204 that isrelatively proximal to the atrial side of the native tricuspid valve maybe attached to the proximal segment 108 of each ventricular arm 106-2(see, e.g., FIG. 3), and a portion of the atrial sealing skirt 204 thatis relatively distal to the atrial side of the native tricuspid valvemay be attached to the distal segment 114 of each atrial arm 106-1. Thecover 200 may extend down through the cylindrical portion 116 of thesupport structure 102 within the elongate central passageway 104. In theexamples of FIGS. 2 and 3, portion 202 of cover 200 that extends downthrough the cylindrical portion 116 of the support structure 102 to helpdefine elongate central passageway 104 ends at or near the ventricularend 120 of cylindrical portion 116. However, in some implementations(see, e.g., FIGS. 17 and 18), cover 200 wraps around the ventricular end120 of the cylindrical portion 116 and terminates along the proximalsegment 112 of each atrial arm 106-1 (e.g., just before the secondarybend 130). In other examples, not explicitly shown, the cover 200 canextend beyond the proximal segment 112 of each atrial arm 106-1 andterminate along the distal segment 110 of each ventricular arm 106-2. Ineither implementation, cover 200 may form a continuous “webbing” ofatrial sealing skirt 204 on the atrial end 118 of the cylindricalportion 116 of the support structure 102 that helps to generate a seal,and also serves as a backstop to the pressure from the ventricular arms106-2 on the ventricular side of the native tricuspid valve leaflets,and prevents the ventricular arms 106-2 from eroding through the nativeleaflets. Atrial sealing skirt 204 may extend to or beyond the nativeannulus of the native tricuspid valve for anchoring and to fully coverthe commissures of the native tricuspid valve for sufficient leakprevention.

In various examples, atrial sealing skirt 204 may initiate at, and beattached to, the distal segment 114 of each atrial arm 106-1, thenswitch to be attached to the proximal segment 108 of each ventriculararm 106-2, then extend down through the elongate central passageway 104,around to the proximal segment 112 of each atrial arm 106-1, and eitherterminate prior to the second bend 130 of each atrial arm 106-1 (e.g.,along the proximal segment of each atrial arm 106-1 at a common distancefrom the cylindrical portion 116), or further extend to the distalsegment 110 of each ventricular arm 106-2 before terminating, in variousimplementations.

In some embodiments, the cover 200 can extend asymmetrically and/ornon-circularly within the elongate central passageway 104 and over oneor more of the atrial arms 106-1 and/or the ventricular arms 106-2. Forexample, in some embodiments, the cover 200 can extend in a “D” shapewithin the elongate central passageway 104 and over one or more of theatrial arms 106-1 and/or the ventricular arms 106-2.

FIG. 3 also shows how prosthetic tricuspid valve 100 may include afenestration feature 300 in a portion of the cover 200 (see also, FIG.13). Fenestration feature 300 may include, for example, a radiopaquemarker, an opening, a magnetic element, a one-way valve, a pop-up valve,a mechanically resizable opening, and increased porosity. In animplanted configuration in which the support structure 102biodynamically fixes the prosthetic tricuspid valve 100 to nativeleaflets of a native tricuspid valve, the fenestration feature 300 canbe disposed between the elongate central passageway 104 and a nativeannulus of the native tricuspid valve.

Fenestration feature 300 may, for example, be a hole or a vent thatallows for passing a guidewire and ancillary devices (e.g. a pacinglead, ICD lead, or another device) through cover 200 and/or the nativetricuspid valve into the ventricle (e.g., for right ventricle and/orpulmonary artery access and beyond). In this way, additional devices canaccess the right ventricle and/or the pulmonary artery without the needto go through elongate central passageway 104 of the prosthetictricuspid valve 100 so as to avoid insufficiency, thrombosis risk,and/or valve damage.

Fenestration feature 300 may include a hole that is identified with aradiopaque marker. Fenestration feature 300 may also have a magneticelement or other mechanism to help with alignment and engagement of asecondary system (e.g. similar to a trans-septal puncture needle) forpassing through the atrial sealing skirt 204 and the native tricuspidvalve to reach the ventricle and beyond. Fenestration feature 300 may beformed from the same material as the atrial sealing skirt 204 or adifferent material (e.g., ePTFE, silicone, or the like) in order tofacilitate sealing of the fenestration feature 300 pre- and post-passingof a device therethrough. Similarly, the fenestration feature 300 caninclude a one-way valve that is separate from the valve structures(e.g., leaflet elements) in the elongate central passageway 104. In someimplementations, fenestration feature 300 may be initially sealed, andconfigured in such a way that it is easily identifiable and able to bepunctured. In other implementations, the entire atrial sealing skirt 204may be manufactured from a material that allows for puncture by astandard or custom ancillary device, and then maintains a sufficientseal to prevent undesirable regurgitant flow after a lead or othercatheter is passed through.

It should also be appreciated that fenestration feature 300 and/or oneor more other features of atrial sealing skirt 204 can be arranged topermanently or temporarily allow a controlled amount of regurgitant flowtherethrough (e.g., to allow relief permanently or temporarily of apressure increase in the ventricle that may be caused by sealing of thenative tricuspid valve by the prosthetic tricuspid valve 100).

In other embodiments, one or more fenestration features, including thefenestration feature 300, may be located radially along the elongatecentral passageway 104 in positions that allow a controlled amount ofregurgitant flow therethrough, while bypassing the cover 200. Forexample, fenestration feature 300 may be implemented as a permanentopening of a predetermined size or a mechanically controllable opening(e.g., an iris or other opening having a diameter, width, or otherdimension that is mechanically controllable and/or changeable at thetime of implantation and/or after implantation). As another example,fenestration feature 300 may be a portion of atrial sealing skirt 204that is more porous than other portions of atrial sealing skirt 204. Afenestration feature 300 that is implemented as a portion of atrialsealing skirt 204 with increased porosity may have a permanentlyincreased porosity or may be formed from a material having a porositythat is initially increased, but decreases (e.g., endothelializes) overtime in the implanted environment to allow a controlled reduction ofregurgitant flow. Alternatively, the entire atrial sealing skirt 204 maybe porous to control the amount of regurgitant flow, and/or may allow adecrease in porosity over time (e.g., through endothelialization) togradually reduce regurgitant flow. In some implementations, fenestrationfeature 300 may have a pressure-controlled component such as a pop-upvalve that allows regurgitant flow when a pressure in the ventriclerises above a predetermined threshold.

FIGS. 4-8 illustrate various prosthetic tricuspid valves 100 in variousstages of implantation into a native tricuspid valve of a heart of apatient. In the example of FIG. 4, prosthetic tricuspid valve 100 iscompacted within a delivery sheath 406 such that cylindrical portion 116(in this example implemented as a cage structure) of support structure102 is radially compressed within sheath 406, and such that the distalsegment 114 of each atrial arm 106-1 and the distal segment 110 of eachventricular arm 106-2 straightened against the exterior surface 147 ofcylindrical portion 116 without extending beyond the length ofcylindrical portion 116.

FIG. 4 also shows a mid layer 404 within sheath 406, a plurality ofrestraints 410, each attached to the distal segment 114 of an atrial arm106-1, an inner nose cone 402, and an outer nose cone 400 (e.g., apigtail nose cone configured to be guided along a guidewire 408 and/orseparate from the guidewire 408). Guidewire 408 may be used to guideprosthetic tricuspid valve 100 into a native tricuspid valve of a heartof a patient via a vein of the patient while the prosthetic tricuspidvalve 100 is in the contracted configuration of FIG. 4 in which thecylindrical portion 116 has a first diameter, each ventricular arm 106-2is held against an exterior surface 147 of the cylindrical portion 116by sheath 406, and each atrial arm 106-1 is held within the sheath 406and against the exterior surface 147 of the cylindrical portion 116 by arespective restraint 410.

As indicated in FIG. 5, sheath 406 may be retracted to allow theventricular arms 106-2 to bend such that the proximal segment 108 ofeach ventricular arm 106-2 extends along the exterior surface 147, andsuch that the distal segment 110 of each ventricular arm 106-2 extendsperpendicularly away from the central axis of cylindrical portion 116.In FIG. 5, prosthetic tricuspid valve 100 has been inserted into thenative tricuspid valve. In FIG. 5, native leaflets 500 and nativechordae tendineae 502 of the native tricuspid valve are visible.

As indicated in FIG. 6, prosthetic tricuspid valve 100 can then beretracted along with the sheath 406 until the distal segment 110 of eachventricular arm 106-2 contacts a ventricular side of native leaflets 500of the native tricuspid valve. It can be seen in FIG. 6 that cylindricalportion 116 is expanding (e.g., due to shape memory features thereof,balloon expansion, or the like) from the contracted configuration ofFIG. 4 having the first diameter, to an expanded configuration with alarger, second diameter to form the elongate central passageway 104 (seealso FIGS. 7 and 8).

As indicated in FIGS. 7 and 8, restraints 410 can then be advanced toallow the atrial arms 106-1 to bend such that the proximal segment 112of each atrial arm 106-1 extends along the exterior surface 147 of thecylindrical portion, and such that the distal segment 114 of each atrialarm 106-1 extends perpendicularly away from the central axis of thecylindrical portion 116 to contact an atrial side of the native leaflets500, and thereby capture the native leaflets 500 against the distalsegments 110 of the ventricular arms 106-2.

Restraints 410 may be constructed of suture, polymer, metal, and/or anyother material, and can serve as a controllably expandable connectionfrom the delivery system to the tips of the atrial arms 106-1 residingon the atrial side of the native leaflets 500. In this way, the atrialarms 106-1 can be extended and expanded as the final step of deploymentprior to assessing valve function, with the connection back to thedelivery system maintained even at full diameter. If the result isundesirable and recapturing is required, the restraints 410 can beactuated in the reverse direction to pull the tips of the atrial arms106-1 back towards the delivery system to reposition and/or recapturethe implant. If positioning and valve function is as desired, then therestraints 410 can be released, and the implant can be fully deployed.

For example, if prosthetic tricuspid valve 100 is desirably positionedin the native tricuspid valve, restraints 410 may be detached from theatrial arms 106-1 for release of the prosthetic tricuspid valve 100 in afully implanted configuration. FIG. 8 shows how support structure 102(including arms 106-1 and 106-2) is configured to biodynamically fix theprosthetic tricuspid valve 100 within, and separated from, a nativeannulus of a native tricuspid valve by grasping native leaflets 500 ofthe native tricuspid valve, without directly attaching to the nativeannulus or native chordae tendineae associated with the native tricuspidvalve.

However, if repositioning or removal of prosthetic tricuspid valve 100from the configuration of FIG. 8 is desired, FIGS. 9-12 show howrestraints 410 can be retracted (FIG. 9) to straighten the atrial arms106-1 against the exterior surface 147 of the cylindrical portion 116 torelease the native leaflets 500, and how sheath 406 can be advanced(FIGS. 10-12) to straighten the ventricular arms 106-2 and compresscentral cylindrical portion 116 for removal of the prosthetic tricuspidvalve 100.

FIGS. 4-12 also illustrate the overbite arrangement of the arms 106during capture of native leaflets 500. Specifically as shown in FIGS.4-12, the atrial arms 106-1 extend from the ventricular end 120 of thecylindrical portion 116 and the ventricular arms 106-2 extend from theatrial end 118 of the cylindrical portion 116. Both the atrial arms106-1 and the ventricular arms 106-2 extend across the cross-sectionalplane of the cylindrical portion 116 of the at least one supportstructure 102 such that there is overbite between the atrial arms 106-1and the ventricular arms 106-2 over the cross-sectional plane duringcapture of native leaflets 500. Although support structure 102 can beimplemented with arms 106 that do not cross over the cross-sectionalplane, and thus do not exhibit overbite (e.g., with atrial arms 106-1extending from the atrial end 118 of the cylindrical portion 116 andventricular arms 106-2 extending from the ventricular end 120 of thecylindrical portion 116), the overbite arrangement described herein(see, e.g., FIGS. 1-12) in which the atrial arms 106-1 and theventricular arms 106-2 cross over twice with respect to thecross-sectional plane of the cylindrical portion 116 has the advantageof facilitating a more robust seal against the native leaflets 500 toprevent paravalvular leak, and also has the advantage of facilitatingthe proper sequencing of deployment (ventricular arms 106-2 followed byatrial arms 106-1), that allows for full assessment and recapturing ofthe prosthetic tricuspid valve 100. Furthermore, having the atrial arms106-1 and the ventricular arms 106-2 extend from opposite ends of thecylindrical portion 116 allows for each set of arms 106-1 and 106-2 tobe compressed against the cylindrical portion 116 itself (rather thanhaving to be fully extended beyond each end of the cylindrical portion116), thereby greatly reducing the overall length of the prosthetictricuspid valve 100 during delivery, and thereby improving flexibilityand ease of positioning and deployment.

FIG. 13 shows a top view of prosthetic tricuspid valve 100 in whichleaflet elements 1300 within elongate central passageway 104 can be seento form an interior of the prosthetic tricuspid valve 100. In theexample of FIG. 13, leaflet elements 1300 are coapted to form a completeseal in the closed configuration of prosthetic tricuspid valve 100.However, as noted above in connection with FIG. 3, it may be desirablein some scenarios to permanently or temporarily allow a controlledamount of regurgitant flow through prosthetic tricuspid valve 100. Inthe example of FIG. 3, various implementations of fenestration feature300 are described for allowing such a controlled regurgitant flow.However, in other implementations, leaflet elements 1300 may be providedwith features or restraints that provide the desired regurgitant flow.For example, a tension line or other mechanical or material features(not shown) may be provided to hold back one or more of the leafletelements 1300 from completely coapting with the other leaflet elements1300, to permanently or temporarily allow a controlled amount ofregurgitant flow between the leaflet elements 1300. A tension line canlater be removed, loosened, or materially altered to reduce or eliminatethe regurgitant flow.

Prosthetic tricuspid valve 100 can be delivered into a native tricuspidvalve from the inferior vena cava that extends up to the superior venacava. The distal portion of the delivery system can be extended to allowa capsule to extend away from the main axis of the delivery system witha preset curvature and flex toward the native tricuspid valve foraxialization and positioning. Extending further into the inferior venacava will increase the curve, while pulling the distal portion back willminimize the curve in this example. FIG. 14 illustrates delivery pathsfrom the inferior vena cava and the superior vena cava.

The delivery system for this transcatheter tricuspid valve implant 100can come from the superior vena cava via the jugular vein, thesubclavian vein, or some other vessel, or from the inferior vena cavavia the femoral vein or an alternative entry point. Alternatively,access could be achieved through surgical access via the right atrium ofthe heart.

For example, the deployment sequence can allow for partial deploymentwithin the atrium before advancing into the ventricle to complete thepositioning and deployment, or the deployment sequence can allow forfull advancement and positioning into the native tricuspid valve beforeinitiating deployment.

The delivery system may be passive or may have multiple planes ofsteering elements. In some implementations, depth control can beprovided by including a steering mechanism of the delivery system thatcan be shuttled proximally or distally relative to the handle of thedelivery system. One example of shuttling the steering mechanismincludes allowing for tensioning of the steering mechanism (for example,relative movement between a base laser cut hypotube and a tension wiremounted to the distal end of that hypotube) inside a subcomponent of thehandle of the delivery system that, itself, can be linearly translatedwithin the handle while maintaining that same relative tension betweenthe steering mechanism.

In some scenarios, the delivery system is advanced from the inferiorvena cava, past the right atrium and into the superior vena cava along aguidewire extending beyond the superior vena cava, with the prosthetictricuspid valve 100 being effectively housed in a portion of thedelivery system positioned within the right atrium. Then, a distalportion of the delivery system is extended up into the superior venacava such that the distal portion of the delivery system is releasedfrom the proximal portion, and is able to flex away from the main axisof the delivery system and towards the native tricuspid valve annulus.The degree to which the distal portion of the delivery system isextended away from the proximal portion of the delivery system controlsthe size of the angle between the proximal portion of the distal portionof the delivery system (where the prosthetic tricuspid valve 100 ishoused) and the main axis of the proximal portion of the deliverysystem, until the prosthetic tricuspid valve 100 is co-axially alignedwith the native tricuspid valve annulus. Delivery features are furtherillustrated in FIGS. 25 and 26 which show separation of a pigtail nosecone 400 from a guidewire 408.

In another example, the delivery system may approach the right atriumfrom the superior vena cava with a guidewire extending down into theinferior vena cava (see, e.g., lower left of FIG. 33). In this example,as the tip of the delivery system approaches the right atrium, thedelivery system may be decoupled from the guidewire so that the deliverysystem can be directed either passively or with active steering, towardsthe annulus of the native tricuspid valve. In this way, the guidewiremay still be used for stability without having to be advanced into theright ventricle where it could cause complications (e.g., perforation,entanglement, conductivity issues, or otherwise). In this example orothers, the outer nose cone 400 of the delivery system may be blunt androunded like a dome, or may be long and flexible in the shape of pigtailsuch that it can be advanced atraumatically into the right ventriclewithout becoming entangled in the chordae of the native tricuspid valve.

FIGS. 15 and 16 respectively show wide- and near-field views of aportion of support structure 102 in which cylindrical portion 116 isformed by a collapsible cage structure (e.g., having a V-shaped strut2200 for capture of the secondary bend 130 of an atrial arm 106-1). Inthe example of FIGS. 15 and 16, the arms 106 are shown before bends 126,124, 128, and 130 are formed therein.

FIGS. 17 and 18 show other arrangements for cover 200 as describedabove.

FIG. 19 shows how the overbite of atrial arms 106-1 and ventricular arms106-2 may be formed closer to the ventricular end 120 of cylindricalportion 116 than illustrated in FIG. 1. In other words, FIG. 19 showshow the cross-sectional plane of the cylindrical portion 116 over whichthe atrial arms 106-1 and ventricular arms 106-2 extend may be formedcloser to the ventricular end 120 of cylindrical portion 116 thanillustrated in FIG. 1

FIG. 20 illustrates how forces 2000 (e.g., by mid layer 404) can beprovided against the cylindrical portion 116 of the support structure102 of the prosthetic tricuspid valve 100 in opposition to restrainingforces 2002 on atrial arms 106-1 of the support structure 102 forcontrol of the capture of native leaflets.

FIG. 21 shows how V-shaped strut 2200 can be formed above the secondarybend 130 of the atrial arm 106-1 which contacts the cylindrical portion116 of support structure 2100 (e.g., support structure 102), in contrastto the implementation of FIG. 22 in which V-shaped strut 2200 residesbelow the secondary bend 2202 (e.g., secondary bend 130) of the atrialarm 106-1 and receives the secondary bend 2202 and steadies the positionof atrial arm 106-1.

FIG. 23 shows spreader arms 2300 that are configured to extend from midlayer 404 to provide force 2000 of FIG. 20 in opposition to therestraining force 2002 of restraints 410. Further details of thearrangement of spreader arms 2300 and restraints 410 are providedhereinafter in connection with FIGS. 35-40.

FIG. 24 shows a side view of a pair of atrial arms 106-1 and ventriculararms 106-2 and illustrates the overbite arrangement of the pair ofatrial arms 106-1 and ventricular arms 106-2, for grasping of the nativeleaflets as in FIG. 8. As shown in FIG. 24, the distal segment 114 ofeach atrial arm 106-1 that extends perpendicularly away from the centralaxis of the elongate central passageway 104 extends from a firstlongitudinal position 2421 along the cylindrical portion 116 of thesupport structure 102. Similarly, the distal segment 110 of eachventricular arm 106-2 that extends away from the central axis of theelongate central passageway 104 extends from a second longitudinalposition 2420 along the cylindrical portion 116 of the support structure102. As shown in FIG. 24, the first longitudinal position 2421 is nearerto the atrial end 118 of the cylindrical portion 116 of the supportstructure 102 than the second longitudinal position 2420 is to theatrial end 118 of the cylindrical portion 116 of the support structure102.

In an implanted configuration of the prosthetic tricuspid valve 100 inwhich the support structure 102 of the prosthetic tricuspid valve 100biodynamically fixes the prosthetic tricuspid valve 100 to the nativeleaflets 500 of the native tricuspid valve, the ventricular arms 106-2in example of FIG. 24 extend from the atrial end 118 of the cylindricalportion 116, through a native annulus of the native tricuspid valve, andinto the ventricle of the heart to contact a ventricular surface of thenative leaflets 500. In this implanted configuration, the atrial arms106-1 extend from the ventricular end 120 of the cylindrical portion116, through the native annulus of the native tricuspid valve, and intothe atrium of the heart to contact an atrial surface of the nativeleaflets 500.

FIG. 24 also shows how bends 126 and 130 can be greater than 90° so thatthe distal segment 114 of each atrial arm 106-1 that extendsperpendicularly away from the central axis of the elongate centralpassageway 104 extends toward the ventricular end 120 of the cylindricalportion 116, and so that the distal segment 110 of each ventricular arm106-2 that extends perpendicularly away from the central axis of theelongate central passageway 104 extends toward the atrial end 118 of thecylindrical portion 116.

FIG. 24 also shows how the distal segment 114 of each atrial arm 106-1that extends perpendicularly away from the central axis of the elongatecentral passageway 104 has a tip 142, the distal segment 110 of eachventricular arm 106-2 that extends perpendicularly away from the centralaxis of the elongate central passageway 104 has a tip 140, and the tips142 are nearer to the ventricular end 120 of the cylindrical portion 116than the tips 140 are to the ventricular end 120 of the cylindricalportion 116. However, as indicated in FIG. 24, the distal segment 114 ofeach atrial arm 106-1 (e.g., the tip 142 of each atrial arm 106-1) mayinclude an extended segment 2400 with a third bend toward the atrial end118 of the cylindrical portion 116 for more atraumatic engagement of theatrial surfaces of the native leaflets, if desired. It should also beappreciated that distal segment 110 of each ventricular arm 106-2 (e.g.,the tip 140 of each ventricular arm 106-2) may also include an extendedsegment with a third bend (e.g., similar to the third bend of theextended segment 2400 of each atrial arm 106-1) toward the ventricularend 120 of the cylindrical portion 116 for more atraumatic engagement ofthe ventricular surfaces of the native leaflets, if desired. It shouldbe noted that the aforementioned third bends can also reduce thefrictional forces exerted by the prosthetic tricuspid valve 100 on theinner surface of the outer sheath 406 by directing the tips of the arms106 away from the inner surface of the outer sheath 406 during loading,delivery, and recapturing of the prosthetic tricuspid valve 100.

Referring again to FIGS. 25 and 26, the delivery system can come from aguidewire 2500 (e.g., guidewire 408) running from the inferior vena cavato the superior vena cava, or from the superior vena cava to theinferior vena cava, where the nose cone 400 and distal portion of thedelivery system separate from the wire track of the guidewire 2500 to anenter the right atrium, go through the native tricuspid valve annulus,and enter into the right ventricle without the guidewire 2500. Thisallows leveraging of the stability of the guidewire 2500 along thestraight portion without the risk of having a guidewire in the rightventricle, which could excite the electrical system of the heart andcause conduction abnormalities. When the guidewire 2500 is pulled out,the nose cone 400 can revert to a flexible “pigtail” like tip that caneasily be passed through the native tricuspid valve annulus withoutgetting tangled in the cords of the native tricuspid valve. In otherembodiments, the guidewire 2500 can be extended into the right atriumfrom either the superior vena cava or the inferior vena cava, and thedelivery system can be advanced such that the nose cone 400 reverts toits “pigtail” shape prior to entering the right ventricle.

FIGS. 27-29 illustrate another implementation of a support structure2702 (e.g., support structure 102) for a prosthetic tricuspid valve 2700in which both atrial arms 2701-1 (e.g., atrial arms 106-1) andventricular arms 2701-2 (e.g., ventricular arms 106-2) may extendinitially from the ventricular end of the support structure 2702, eacharm 2701 having an initial bend of 180° +/−45° that directs the arm 2701back towards the atrial end of the support structure 2702. In thisexample, each atrial arm 2701-1 extends through an annulus of a nativetricuspid valve and has a secondary bend closer in proximity to theatrial end of the support structure 2720 than a secondary bend of eachventricular arm 2701-2. The secondary bend of each arm 2702 issufficient to position the distal segment of the arm 2702 beyond thesecondary bend of the arm 2702 perpendicular to a central axis of anelongate central passageway defined by the support structure 2702.However, in this example, the degrees of the secondary bends of the arms2702 are such that the tips of the atrial arms 2701-1 are closer inproximity to the ventricular end of the support structure 2702 than thetips of the ventricular arms 2701-2. Thus, the arrangement of the atrialarms 2701-1 and the ventricular arms 2701-2 above and below the nativeleaflets would again result in the corrugated, ruffled-collarconfiguration to ensure a tight seal and more stable positioning of theprosthetic tricuspid valve 2700.

In yet another implementation, both the atrial arms 2701-1 and theventricular arms 2701-2 extend initially from the atrial end of thesupport structure 2702. Leaflet elements 1300 described in connectionwith prosthetic tricuspid valve 100 can also be used with thealternative support structures 2702 of FIGS. 27-30, as indicated in FIG.29. In one exemplary implementation, as shown in FIG. 30, each atrialarm 2701-1 can be folded up against the exterior surface 147 of thesupport structure 2702 during loading, while each ventricular arm 2701-2can be extended down toward and beyond the ventricular end of thesupport structure 2702 during loading.

FIGS. 31-34 illustrate various features prosthetic tricuspid valves inwhich atrial and ventricular arms originate and extend from oppositeends of a cylindrical portion of a support structure of the prosthetictricuspid valves (e.g., in which ventricular arms originate and extendfrom an atrial end of the cylindrical portion of the support structureand in which atrial arms originate and extend from a ventricular end ofthe cylindrical portion of the support structure). These variousfeatures can applied to any of the implementations described above andbelow, if desired.

FIG. 35 illustrates additional features of spreader arms 2300 asdescribed above in connection with FIG. 23 (e.g., for providing forces2000 and 2002 of FIG. 20 for controlled deployment or retraction ofventricular arms 106-2). As shown in the example of FIG. 35, a pluralityof spreader arms 2300 can extend from circumferentially separatedlocations on mid layer 404 and can be configured to spread radiallyapart upon retraction of outer sheath 406.

Each spreader arm 2300 can be coupled to the atrial end 118 of thecylindrical portion 116 of the support structure 102 in such a way thatthe spread of spreader arms 2300 allows cylindrical portion 116 ofprosthetic tricuspid valve 100 to expand radially, while spreader arms2300 provide a force in a ventricular direction against supportstructure 102, that opposes the atrial-directed force of restraints 410on atrial arms 106-1. Spreader arms 2300 may be formed from a 3D printedor molded material (e.g., a polymer) that is flexible enough that it canbe compressed into sheath 406 and then flare back out naturally into theconfiguration of FIG. 35 upon retraction of sheath 406. In the exampleof FIG. 35, each restraint 410 for each atrial arm 106-1 is implementedas a suture that extends from a gap 3508 between spreader arms 2300,through an eyelet 3502 in the atrial arm 106-1, and back through gap3508 between spreader arms 2300. Once the desired implantation positionfor prosthetic tricuspid valve 100 is achieved, restraints 410 can becut and removed.

FIG. 36 illustrates a perspective view of spreader arms 2300 extendingfrom mid layer 404, in which interlocking mechanisms 3600 forinterfacing with the atrial end 118 of the cylindrical portion 116 ofthe support structure 102 can be seen. Each interlocking mechanism 3600is configured to maintain contact with the atrial end 118 of thecylindrical portion 116 of the support structure 102 such that spreaderarms 2300 can push on the at least one support structure 102 in aventricular direction. In some embodiments, the interlocking mechanisms3600 can maintain contact with the atrial end 118 of the cylindricalportion 116 of the support structure 102 both during active pushing ofthe spreader arms 2300, and during passive rest of the spreader arms2300. In some embodiments, the interlocking mechanisms 3600 candisengage from the atrial end 118 of the cylindrical portion 116 of thesupport structure 102 during passive rest of the spreader arms 2300 whenmid layer 404 is moved away from support structure 102.

As shown in FIG. 36, each spreader arm 2300 may include an extension3602 that extends beyond the interlocking mechanism 3600 on the spreaderarm, and over the atrial end 118 of the cylindrical portion 116 of theat least one support structure 102. The extension 3602 may servemultiple purposes. First, extension 3602 can serve as a “hood” over thesupport structure 102 that allows for easier recapturing of theprosthetic tricuspid valve 100 with lower forces by preventing the outersheath 406 from encountering resistance from an edge of the supportstructure 102 as the outer sheath 406 is advanced back over the edge ofthe support structure 102 during recapturing. In addition, extension3602 can extend to promote pleating of the atrial sealing skirt 204 andto provide a hinge point for controlled folding of the atrial sealingskirt 204, to again reduce loading and recapturing forces that wouldotherwise cause the atrial sealing skirt 204 to bunch non-uniformly asthe atrial arms 106-1 are folded up.

In the examples of FIGS. 35 and 36, spreader arms 2300 engage with theproximal segment 108 of each ventricular arm 106-2 (e.g., the initialbend 124 of each ventricular arm 106-2) at the atrial end 118 of thecylindrical portion 116 of the support structure 102. However, it shouldbe appreciated that spreader arms 2300 can be alternatively oradditionally provided to engage with the cylindrical portion 116 of thesupport structure 102, as shown in the examples of FIGS. 59-60.

FIG. 37 illustrates a wider perspective view of support structure 102coupled to restraints 410 and spreader arms 2300 of mid layer 404, inwhich inner nose cone 402 and outer nose cone 400 can be seen extendingthrough elongate central passageway 104. Prosthetic tricuspid valve 100may be disposed in the configuration of FIG. 37 during implantation andprior to removal of inner nose cone 402, outer nose cone 400, spreaderarms 2300, restraints 410, and sheath 406, to finalize implantation.

FIG. 38 illustrates a perspective view of a portion of mid layer 404 inaccordance with aspects of the disclosure. As illustrated by FIG. 38,suture lines that form restraints 410 can run the full length of thedelivery system (e.g., within elongate openings 3804 in an outer layer3800 of mid layer 404). If desired, these suture lines can be coupled tosprings 3801 on an end of the delivery system to accommodate any flex inan end of the delivery system that is configured to be proximal to theventricular side of the native tricuspid valve and that could change inrelative length. Springs 3801 may be mounted, for example, in openings3806 in an inner layer 3802 of mid layer 404. From springs 3801, thesuture lines can run down the inner diameter, through one of the armeyelets 3502 (see FIG. 35), and then back down through the gaps 3508between spreader arms 2300. In one example implementation, nine spreaderarms 2300 can alternate circumferentially with nine suture lines. Oneend of each suture line can extend from mid layer 404 at an end of thedelivery system that is configured to be proximal to the atrial side ofthe native tricuspid vale, so that the end can be cut to allow thesuture line to be pulled out around the inner diameter.

In the examples of FIGS. 35 and 37, support structure 102 of prosthetictricuspid valve 100 is shown interfacing with spreader arms 2300 andrestraints 410 without the other portions of the prosthetic tricuspidvalve 100, simply for clarity. FIG. 39 illustrates the completeprosthetic tricuspid valve 100, including leaflet elements 1300 andcover 200, including atrial sealing skirt 204, interfacing with thedelivery system. For additional clarity, FIG. 40 illustrates aperspective view of support structure 102 and spreader arms 2300 shownin partial transparency, particularly for clarity of the interfacesbetween interlocking mechanisms 3600 and bends 124 of ventricular arms106-2.

FIG. 41 illustrates a perspective view of support structure 102 in aconfiguration in which atrial arms 106-1, ventricular arms 106-2, andcylindrical portion 116 are cut from a common structure. In the exampleof FIG. 41, support structure 102 is shown “as-cut” (e.g., with atrialarms 106-1 and ventricular arms 106-2 shown before bends 126, 124, 128,and 130 are formed therein to modify the configuration of segments 108,110, 112, and 114 to mirror those shown in, for example, FIG. 1). FIG.41 also illustrates example configurations for ventricular arm tips 140and atrial arm tips 142. However, the configurations of tips 140 and 142can be provided with various different geometries to optimize loaddistribution against the native leaflets. In the configuration of FIG.41, cylindrical portion 116 is formed from an expandable cage structurethat is depicted in a contracted configuration.

FIGS. 42A-B illustrate the prosthetic tricuspid valve 100 implanted in anative tricuspid valve of a heart 4200 throughout alternating pressuredifferentials on either side of the native tricuspid valve 100 duringcardiac cycles of the heart 4200.

Specifically, FIG. 42A illustrates the prosthetic tricuspid valve 100implanted in the native tricuspid valve of the heart 4200 duringdiastolic filling of a ventricle 4202 of the heart 4200. Duringdiastolic filling of the ventricle 4202 of the heart 4200, blood flowsfrom an atrium 4201 of the heart 4200, through the elongate centralpassageway 104 of the prosthetic tricuspid valve 100, and into theventricle 4202 of the heart 4200. During diastolic filling of theventricle 4202 of the heart 4200, pressure on the prosthetic tricuspidvalve 100 is relieved as the prosthetic tricuspid valve 100 movesslightly towards the ventricle 4202 of the heart 4200. The atrial arms106-1 resist this motion, while the ventricular arms 106-2 relax tomaintain contact with the ventricular side of the native tricuspid valveleaflets.

Conversely, FIG. 42B illustrates the prosthetic tricuspid valve 100implanted in the native tricuspid valve of the heart 4200 duringsystolic contraction of the ventricle 4202 of the heart 4200. Duringsystolic contraction of the ventricle 4202 of the heart 4200, bloodflows out of the ventricle 4202 of the heart 4200 and into a pulmonaryartery 4203 of the heart 4200. During systolic contraction of theventricle 4202 of the heart 4200, pressure on the prosthetic tricuspidvalve 100 moves the prosthetic tricuspid valve 100 slightly towards theatrium 4201 of the heart 4200. The ventricular arms 106-2 resist thismotion while the atrial arms 106-1 relax to maintain contact with theatrial side of the native tricuspid valve leaflets. This also creates atrampoline effect where the ventricular systolic pressure load can bepartially absorbed by the atrial motion of the native leaflets.

FIG. 43A-B illustrate another implementation of a support structure 102for a prosthetic tricuspid valve, in accordance with an embodiment.Specifically, FIG. 43A illustrates another implementation of a supportstructure 102 for a prosthetic tricuspid valve in a contractedconfiguration, and defining an elongate central passageway having afirst diameter. FIG. 43B illustrates another implementation of a supportstructure 102 for a prosthetic tricuspid valve in an expandedconfiguration, and defining an elongate central passageway having asecond diameter that is larger than the first diameter. For example, inthe embodiment of FIGS. 43A-B, the first diameter of the elongatecentral passageway can be 8 mm, while the second diameter of theelongate central passageway can be 25 mm.

As discussed above, a prosthetic tricuspid valve described herein caninclude one or more support structures. For example, the prosthetictricuspid valve described herein can include one, two, three, or morethan three support structures. At least one of the one or more supportstructures includes a cylindrical portion having an atrial end and aventricular end. The cylindrical portion of the at least one supportstructure defines an elongate central passageway of the prosthetictricuspid valve. The Detailed Description of certain figures above andbelow describe exemplar prosthetic tricuspid valves including onesupport structure. Additionally, the Detailed Description of certainfigures above and below describe exemplar prosthetic tricuspid valvesincluding more than one (e.g., two, three, or more than three) supportstructures. For example, the Detailed Description of FIGS. 46-53 belowdescribe exemplar prosthetic tricuspid valves having two or threesupport structures. However, many of the features of prosthetictricuspid valves that are described with reference to a prosthetictricuspid valve having a particular number of support structures can beincluded in other prosthetic tricuspid valves having a different numberof support structures.

FIGS. 44-45 illustrate different views of an implementation of aprosthetic tricuspid valve 4400 having one support structure 102, inaccordance with an embodiment.

FIG. 44A illustrates a view of the flattened support structure 102 ofthe prosthetic tricuspid valve 4400 having one support structure 102, inaccordance with an embodiment.

FIG. 44B illustrates a side view of the prosthetic tricuspid valve 4400having one support structure 102 and configured for implantation in anative tricuspid valve, in accordance with an embodiment.

FIGS. 45A-D illustrate computer-aided design (CAD) drawings of differentviews of the prosthetic tricuspid valve 4400 having one supportstructure 102, in accordance with an embodiment. FIG. 45A illustrates aCAD drawing of a side view of the prosthetic tricuspid valve 4400 havingone support structure 102, in accordance with an embodiment. FIG. 45Billustrates a CAD drawing of a top-down view of the prosthetic tricuspidvalve 4400 having one support structure 102, in accordance with anembodiment. FIG. 45C illustrates a CAD drawing of a titled side view ofthe prosthetic tricuspid valve 4400 having one support structure 102, inaccordance with an embodiment. FIG. 45D illustrates a CAD drawing of aside view of the prosthetic tricuspid valve 4400 having one supportstructure 102, in accordance with an embodiment.

In the embodiment of the prosthetic tricuspid valve 4400 having onesupport structure 102, both the atrial arms 106-1 and the ventriculararms 106-2 are formed from the one support structure 102. As describedthroughout this disclosure, the one support structure 102 also includesa cylindrical portion 116 that defines an elongate central passageway104 of the prosthetic tricuspid valve 4400.

The advantages to forming the prosthetic tricuspid valve 4400 from onesupport structure 102 include reduction of a diameter of the prosthetictricuspid valve 4400, and fewer steps for assembly of the prosthetictricuspid valve 4400. However, one disadvantage to forming theprosthetic tricuspid valve 4400 from one support structure 102 is morecomplex manufacturing of the prosthetic tricuspid valve 4400. Anotherdisadvantage to forming the prosthetic tricuspid valve 4400 from onesupport structure 102 is that the prosthetic tricuspid valve 4400 maynot distribute load effectively, and thus certain portions of theprosthetic tricuspid valve 4400 may be easily fractured under stress.Specifically, as discussed in further detail below, forming theprosthetic tricuspid valve 4400 from one support structure 102 canresult in the prosthetic tricuspid valve 4400 having shorter arms 106,as well as fulcrum points occurring in the same general location as loadnodes, effectively yielding less ability for load distribution and thusgreater breakability of the prosthetic tricuspid valve 4400.

FIGS. 46-47 illustrate different views of an implementation of aprosthetic tricuspid valve 4600 having two support structures 102-1 and102-2, in accordance with an embodiment.

FIG. 46A illustrates a view of the flattened support structures 102-1and 102-2 of the prosthetic tricuspid valve 4600 having two supportstructures 102-1 and 102-2, in accordance with an embodiment.

FIG. 46B illustrates a side view of the prosthetic tricuspid valve 4600having two support structures 102-1 and 102-2 and configured forimplantation in a native tricuspid valve, in accordance with anembodiment.

FIGS. 47A-F illustrate CAD drawings of different views of the prosthetictricuspid valve 4600 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 47A illustrates a CAD drawing of atilted side view of the support structure 102-1 of the prosthetictricuspid valve 4600 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 47B illustrates a CAD drawing of atilted side view of the support structure 102-2 of the prosthetictricuspid valve 4600 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 47C illustrates a CAD drawing of aside view of the prosthetic tricuspid valve 4600 having two supportstructures 102-1 and 102-2, in accordance with an embodiment. FIG. 47Dillustrates a CAD drawing of a top-down view of the prosthetic tricuspidvalve 4600 having two support structures 102-1 and 102-2, in accordancewith an embodiment. FIG. 47E illustrates a CAD drawing of a tilted sideview of the prosthetic tricuspid valve 4600 having two supportstructures 102-1 and 102-2, in accordance with an embodiment. FIG. 47Fillustrates a CAD drawing of another side view of the prosthetictricuspid valve 4600 having two support structures 102-1 and 102-2, inaccordance with an embodiment.

In the embodiment of the prosthetic tricuspid valve 4600 having twosupport structures 102-1 and 102-2, the atrial arms 106-1 are formedfrom the first support structure 102-1 and the ventricular arms 106-2are formed from the second support structure 102-2. The two supportstructures 102-1 and 102-2 are configured to fit together to form theprosthetic tricuspid valve 4600. As described throughout thisdisclosure, at least one of the two support structures 102-1 and 102-2includes a cylindrical portion that defines an elongate centralpassageway 104 of the prosthetic tricuspid valve 4600. For example, inthe implementation of the prosthetic tricuspid valve 4600 having twosupport structures 102-1 and 102-2 depicted in FIGS. 46-47, each supportstructure of the two support structures 102-1 and 102-2 includes acylindrical portion, 116-1 and 116-2, respectively, that define theelongate central passageway 104 of the prosthetic tricuspid valve 4600.However, in alternative embodiments, only one of the two supportstructures 102-1 and 102-2 may include a cylindrical portion to definethe elongate central passageway 104 of the prosthetic tricuspid valve4600.

An advantage to forming the prosthetic tricuspid valve 4600 from the twosupport structures 102-1 and 102-2 includes simpler manufacturing of theprosthetic tricuspid valve 4600. However, a disadvantage to forming theprosthetic tricuspid valve 4600 from the two support structures 102-1and 102-2 is that assembly of the prosthetic tricuspid valve 4600includes an additional step of fitting the two support structures 102-1and 102-2 together to form the prosthetic tricuspid valve 4600. Anotheradvantage to forming the prosthetic tricuspid valve 4600 from the twosupport structures 102-1 and 102-2 is that there is improved loaddistribution in the ventricular arms 106-2, which is important becausethe ventricular arms 106-2 experience greater forces than the atrialarms 106-1 when the prosthetic tricuspid valve 4600 is implanted invivo.

FIGS. 48-49 illustrate different views of an implementation of aprosthetic tricuspid valve 4800 having two support structures 102-1 and102-2, in accordance with an embodiment.

FIG. 48A illustrates a view of the flattened support structures 102-1and 102-2 of the prosthetic tricuspid valve 4800 having two supportstructures 102-1 and 102-2, in accordance with an embodiment.

FIG. 48B illustrates a side view of the prosthetic tricuspid valve 4800having two support structures 102-1 and 102-2 and configured forimplantation in a native tricuspid valve, in accordance with anembodiment.

FIGS. 49A-F illustrate CAD drawings of different views of the prosthetictricuspid valve 4800 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 49A illustrates a CAD drawing of atilted side view of the support structure 102-1 of the prosthetictricuspid valve 4800 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 49B illustrates a CAD drawing of atilted side view of the support structure 102-2 of the prosthetictricuspid valve 4800 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 49C illustrates a CAD drawing of aside view of the prosthetic tricuspid valve 4800 having two supportstructures 102-1 and 102-2, in accordance with an embodiment. FIG. 49Dillustrates a CAD drawing of a top-down view of the prosthetic tricuspidvalve 4800 having two support structures 102-1 and 102-2, in accordancewith an embodiment. FIG. 49E illustrates a CAD drawing of a tilted sideview of the prosthetic tricuspid valve 4800 having two supportstructures 102-1 and 102-2, in accordance with an embodiment. FIG. 49Fillustrates a CAD drawing of another side view of the prosthetictricuspid valve 4800 having two support structures 102-1 and 102-2, inaccordance with an embodiment.

In the embodiment of the prosthetic tricuspid valve 4800 having twosupport structures 102-1 and 102-2, the ventricular arms 106-2 areformed from the first support structure 102-1 and the atrial arms 106-1are formed from the second support structure 102-2. The two supportstructures 102-1 and 102-2 are configured to fit together to form theprosthetic tricuspid valve 4800. As described throughout thisdisclosure, at least one of the two support structures 102-1 and 102-2includes a cylindrical portion that defines an elongate centralpassageway 104 of the prosthetic tricuspid valve 4800. For example, inthe implementation of the prosthetic tricuspid valve 4800 having twosupport structures 102-1 and 102-2 depicted in FIGS. 48-49, each supportstructure of the two support structures 102-1 and 102-2 includes acylindrical portion, 116-1 and 116-2, respectively, that define theelongate central passageway 104 of the prosthetic tricuspid valve 4800.However, in alternative embodiments, only one of the two supportstructures 102-1 and 102-2 may include a cylindrical portion to definethe elongate central passageway 104 of the prosthetic tricuspid valve4800.

An advantage to forming the prosthetic tricuspid valve 4800 from the twosupport structures 102-1 and 102-2 includes simpler manufacturing of theprosthetic tricuspid valve 4800, as with the prosthetic tricuspid valve4600. Another advantage to forming the prosthetic tricuspid valve 4800from the two support structures 102-1 and 102-2 is that the leafletelements can be formed from the first support structure 102-1 whichforms the ventricular arms 106-2 rather than the atrial arms 106-1,thereby enabling an atrial sealing skirt as discussed above to be formedseparately from the leaflet elements, by the second support structure102-2 forming the atrial arms 106-1. By forming the atrial sealing skirtfrom the second support structure 102-2, separate from the leafletelements formed from the first support structure 102-1, assembly of theindividual support structures 102-1 and 102-2 is simpler, and the atrialsealing skirt can be laminated. However, assembly of the prosthetictricuspid valve 4800 still includes an additional step of fitting thetwo support structures 102-1 and 102-2 together to form the prosthetictricuspid valve 4800. Another advantage to forming the prosthetictricuspid valve 4800 from the two support structures 102-1 and 102-2 isthat there is improved load distribution, but mainly in the atrial arms106-1, which is less important because the atrial arms 106-1 experienceless force than the ventricular arms 106-2 when the prosthetic tricuspidvalve 4800 is implanted in vivo.

FIGS. 50-51 illustrate different views of an implementation of aprosthetic tricuspid valve 5000 having two support structures 102-1 and102-2, in accordance with an embodiment.

FIG. 50A illustrates a view of the flattened support structures 102-1and 102-2 of the prosthetic tricuspid valve 5000 having two supportstructures 102-1 and 102-2, in accordance with an embodiment.

FIG. 50B illustrates a side view of the prosthetic tricuspid valve 5000having two support structures 102-1 and 102-2 and configured forimplantation in a native tricuspid valve, in accordance with anembodiment.

FIGS. 51A-F illustrate CAD drawings of different views of the prosthetictricuspid valve 5000 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 51A illustrates a CAD drawing of atilted side view of the support structure 102-1 of the prosthetictricuspid valve 5000 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 51B illustrates a CAD drawing of atilted side view of the support structure 102-2 of the prosthetictricuspid valve 5000 having two support structures 102-1 and 102-2, inaccordance with an embodiment. FIG. 51C illustrates a CAD drawing of aside view of the prosthetic tricuspid valve 5000 having two supportstructures 102-1 and 102-2, in accordance with an embodiment. FIG. 51Dillustrates a CAD drawing of a top-down view of the prosthetic tricuspidvalve 5000 having two support structures 102-1 and 102-2, in accordancewith an embodiment. FIG. 51E illustrates a CAD drawing of a tilted sideview of the prosthetic tricuspid valve 5000 having two supportstructures 102-1 and 102-2, in accordance with an embodiment. FIG. 51Fillustrates a CAD drawing of another side view of the prosthetictricuspid valve 5000 having two support structures 102-1 and 102-2, inaccordance with an embodiment.

In the embodiment of the prosthetic tricuspid valve 5000 having twosupport structures 102-1 and 102-2, the first support structure 102-1does not form the atrial arms 106-1 or the ventricular arms 106-2. Thesecond support structure 102-2 forms both the atrial arms 106-1 and theatrial arms 106-1. In some embodiments, the second support structure102-2 forming both the atrial arms 106-1 and the atrial arms 106-1 canbe the prosthetic tricuspid valve 4400 having the one support structure102. The two support structures 102-1 and 102-2 are configured to fittogether to form the prosthetic tricuspid valve 5000. As describedthroughout this disclosure, at least one of the two support structures102-1 and 102-2 includes a cylindrical portion that defines an elongatecentral passageway 104 of the prosthetic tricuspid valve 5000. Forexample, in the implementation of the prosthetic tricuspid valve 5000having two support structures 102-1 and 102-2 depicted in FIGS. 50-51,each support structure of the two support structures 102-1 and 102-2includes a cylindrical portion, 116-1 and 116-2, respectively, thatdefine the elongate central passageway 104 of the prosthetic tricuspidvalve 5000. However, in alternative embodiments, only one of the twosupport structures 102-1 and 102-2 may include a cylindrical portion todefine the elongate central passageway 104 of the prosthetic tricuspidvalve 5000.

Like the prosthetic tricuspid valves 4600 and 4800, an advantage toforming the prosthetic tricuspid valve 5000 from the two supportstructures 102-1 and 102-2 includes simpler manufacturing of theprosthetic tricuspid valve 5000. Additionally, like the prosthetictricuspid valve 4800, another advantage to forming the prosthetictricuspid valve 5000 from the two support structures 102-1 and 102-2 isthat the leaflet elements can be formed from the first support structure102-1 which does not form the atrial arms 106-1, thereby enabling anatrial sealing skirt as discussed above to be formed separately from theleaflet elements, by the second support structure 102-2 forming theatrial arms 106-1. By forming the atrial sealing skirt from the secondsupport structure 102-2, separate from the leaflet elements formed fromthe first support structure 102-1, assembly of the individual supportstructures 102-1 and 102-2 is simpler, and the atrial sealing skirt canbe laminated. However, assembly of the prosthetic tricuspid valve 5000still includes an additional step of fitting the two support structures102-1 and 102-2 together to form the prosthetic tricuspid valve 5000.Another advantage to forming the prosthetic tricuspid valve 5000 fromthe two support structures 102-1 and 102-2 is that there is improvedload distribution because the first support structure 5000-1 can provideadditional reinforcement to the atrial arms 106-1 and to the ventriculararms 106-2 formed from the second support structure 5000-2. However, thearms 106 are not still not extended, and the fulcrum points still occurin the same general location as load nodes, effectively yielding lessability for load distribution and thus greater breakability of theprosthetic tricuspid valve 5000.

FIGS. 52-53 illustrate different views of an implementation of aprosthetic tricuspid valve 5200 having three support structures 102-1,102-2, and 102-3, in accordance with an embodiment.

FIG. 52A illustrates a view of the flattened support structures 102-1,102-2, and 102-3 of the prosthetic tricuspid valve 5200 having threesupport structures 102-1, 102-2, and 102-3, in accordance with anembodiment.

FIG. 52B illustrates a side view of the prosthetic tricuspid valve 5200having three support structures 102-1, 102-2, and 102-3 and configuredfor implantation in a native tricuspid valve, in accordance with anembodiment.

FIGS. 53A-G illustrate CAD drawings of different views of the prosthetictricuspid valve 5200 having three support structures 102-1, 102-2, and102-3, in accordance with an embodiment. FIG. 53A illustrates a CADdrawing of a tilted side view of the support structure 102-1 of theprosthetic tricuspid valve 5200 having three support structures 102-1,102-2, and 102-3, in accordance with an embodiment. FIG. 53B illustratesa CAD drawing of a tilted side view of the support structure 102-2 ofthe prosthetic tricuspid valve 5200 having three support structures102-1, 102-2, and 102-3, in accordance with an embodiment. FIG. 53Cillustrates a CAD drawing of a tilted side view of the support structure102-3 of the prosthetic tricuspid valve 5200 having three supportstructures 102-1, 102-2, and 102-3, in accordance with an embodiment.FIG. 53D illustrates a CAD drawing of a side view of the prosthetictricuspid valve 5200 having three support structures 102-1, 102-2, and102-3, in accordance with an embodiment. FIG. 53E illustrates a CADdrawing of a top-down view of the prosthetic tricuspid valve 5200 havingthree support structures 102-1, 102-2, and 102-3, in accordance with anembodiment. FIG. 53F illustrates a CAD drawing of a tilted side view ofthe prosthetic tricuspid valve 5200 having three support structures102-1, 102-2, and 102-3, in accordance with an embodiment. FIG. 53Gillustrates a CAD drawing of another side view of the prosthetictricuspid valve 5200 having three support structures 102-1, 102-2, and102-3, in accordance with an embodiment.

In the embodiment of the prosthetic tricuspid valve 5200 having threesupport structures 102-1, 102-2, and 102-3, the first support structure102-1 does not form the atrial arms 106-1 or the ventricular arms 106-2.The second support structure 102-2 forms the ventricular arms 106-2. Thethird support structure 102-3 forms the atrial arms 106-1. The threesupport structures 102-1, 102-2, and 102-3 are configured to fittogether to form the prosthetic tricuspid valve 5200. As describedthroughout this disclosure, at least one of the three support structures102-1, 102-2, and 102-3 includes a cylindrical portion that defines anelongate central passageway 104 of the prosthetic tricuspid valve 5200.For example, in the implementation of the prosthetic tricuspid valve5200 having three support structures 102-1, 102-2, and 102-3 depicted inFIGS. 52-53, each support structure of the three support structures102-1, 102-2, and 102-3 includes a cylindrical portion, 116-1, 116-2,and 116-3, respectively, that define the elongate central passageway 104of the prosthetic tricuspid valve 5200. However, in alternativeembodiments, only one or two of the three support structures 102-1,102-2, and 102-3 may include a cylindrical portion to define theelongate central passageway 104 of the prosthetic tricuspid valve 5200.

Like the prosthetic tricuspid valves 4600, 4800, and 5000, an advantageto forming the prosthetic tricuspid valve 5200 from the three supportstructures 102-1, 102-2, and 102-3 includes simpler manufacturing of theprosthetic tricuspid valve 5200. Additionally, like the prosthetictricuspid valves 4800 and 5000, another advantage to forming theprosthetic tricuspid valve 5200 from the three support structures 102-1,102-2, and 102-3 is that the leaflet elements can be formed from thefirst support structure 102-1 which does not form the atrial arms 106-1,thereby enabling an atrial sealing skirt as discussed above to be formedseparately from the leaflet elements, by the third support structure102-3 forming the atrial arms 106-1. By forming the atrial sealing skirtfrom the third support structure 102-3, separate from the leafletelements formed from the first support structure 102-1, assembly of theindividual support structures 102-1 and 102-3 is simpler, and the atrialsealing skirt can be laminated. However, assembly of the prosthetictricuspid valve 5200 still includes an additional step of fitting thethree support structures 102-1, 102-2, and 102-3 together to form theprosthetic tricuspid valve 5200. Another advantage to forming theprosthetic tricuspid valve 5200 from the three support structures 102-1,102-2, and 102-3 is that there is improved load distribution because thefirst support structure 102-1 can provide additional reinforcement tothe atrial arms 106-1 formed from the third support structure 102-3, andthe first support structure 102-1 and the third support structure 102-3can both provide additional reinforcement to the ventricular arms 106-2formed from the second support structure 102-2. Furthermore, unlike theprosthetic tricuspid valves 4600, 4800, and 5000 described above, thearms 106 extend such that fulcrum points occur in multiple differentlocations apart from nodes receiving load forces, effectively yieldinggreater load distribution and thus less breakability of the prosthetictricuspid valve 5200. However, disadvantageously, forming the prosthetictricuspid valve 5200 from the three support structures 102-1, 102-2, and102-3 causes the overall bulkiness and diameter of the prosthetictricuspid valve 5200 to increase.

FIG. 54A illustrates a side view of overbite between an atrial arm 106-1and a ventricular arm 106-2 of the prosthetic tricuspid valve 100 atrest, in accordance with an embodiment. In other words, FIG. 54Aillustrates a side view of overbite between the atrial arm 106-1 and theventricular arm 106-2 of the prosthetic tricuspid valve 100 when theprosthetic tricuspid valve 100 is not implanted in a native tricuspidvalve.

FIG. 54B illustrates a side view of the atrial arm 106-1 and theventricular arm 106-2 of the prosthetic tricuspid valve 100 when theprosthetic tricuspid valve 100 is implanted in a native tricuspid valve,in accordance with an embodiment. In other words, FIG. 54B illustrates aside view of the atrial arm 106-1 and the ventricular arm 106-2 of theprosthetic tricuspid valve 100 when the arms 106 are clamping onto anative leaflet of the native tricuspid valve in which the prosthetictricuspid valve 100 is implanted. The amount of overbite between theatrial arm 106-1 and the ventricular arm 106-2 of the prosthetictricuspid valve 100 when the prosthetic tricuspid valve 100 is at rest,as shown in FIG. 54A, determines the magnitude of the clamping force ofthe arms 106 on the native leaflet of the native tricuspid valve.

FIG. 55 illustrates a CAD drawing of a cut-away side view of theprosthetic tricuspid valve 5200 having three support structures 102-1,102-2, and 102-3, in accordance with an embodiment. As mentioned above,the first support structure 102-1 does not form the atrial arms 106-1 orthe ventricular arms 106-2. The second support structure 102-2 forms theventricular arms 106-2, and the third support structure 102-3 forms theatrial arms 106-1. The three support structures 102-1, 102-2, and 102-3are configured to fit together to form the prosthetic tricuspid valve5200. Specifically, to fit the three support structures 102-1, 102-2,and 102-3 together to form the prosthetic tricuspid valve 5200, a radiusof curvature of a secondary bend 130 of each atrial arm 106-1 isreceived by a V-shaped strut 2200-1 of the first support structure102-1. Additionally, to fit the three support structures 102-1, 102-2,and 102-3 together to form the prosthetic tricuspid valve 5200, a radiusof curvature of a secondary bend 126 of each ventricular arm 106-2 isreceived by a V-shaped strut 2200-1 of the support structure 102-1, andalso contacts a mirror V-shaped strut 2200-3 of the support structure102-3 that forms the atrial arms 106-1.

Furthermore, to enable the three support structures 102-1, 102-2, and102-3 to fit together to form the prosthetic tricuspid valve 5200,dimensions of the three support structures 102-1, 102-2, and 102-3 canbe determined relative to one another. For example, in some embodiments,a minimum inner diameter of the cylindrical portion(s) of the at leastone support structure that defines the elongate central passageway 104can be less than a maximum outer diameter of the elongate centralpassageway 104. As discussed above, in the implementation of theprosthetic tricuspid valve 5200, each support structure of the threesupport structures 102-1, 102-2, and 102-3 includes a cylindricalportion, 116-1, 116-2, and 116-3, respectively, that define the elongatecentral passageway 104 of the prosthetic tricuspid valve 5200.Therefore, in some embodiments, a minimum inner diameter of thecylindrical portions 116-1, 116-2, and 116-3 of the three supportstructures 102-1, 102-2, and 102-3, respectively, that define theelongate central passageway 104 can be less than a maximum outerdiameter of the elongate central passageway 104. As another example, insome embodiments, a minimum diameter of a radius of curvature of eachbend of each arm 106, where the arm 106 extends perpendicularly awayfrom the central axis of the elongate central passageway 104, is lessthan the maximum outer diameter of the elongate central passageway 104.In other words, in some embodiments, a minimum diameter of a radius ofcurvature of the secondary bend 130 of each atrial arm 106-1 and of thesecondary bend 126 of each ventricular arm 106-2 is less than themaximum outer diameter of the elongate central passageway 104. Theserelative dimensions can facilitate the three support structures 102-1,102-2, and 102-3 fitting together to form the prosthetic tricuspid valve5200.

FIGS. 56A-C are images of a prototype prosthetic tricuspid valve 5600,in accordance with an embodiment. Specifically, FIG. 56A is a top-downview of an image of the prototype prosthetic tricuspid valve 5600clamping onto a sheet of paper oriented approximately perpendicular(e.g., 90° +/−45°) to the central axis of an elongate central passageway104 of the prosthetic tricuspid valve 5600, in accordance with anembodiment. FIG. 56B is a bottom-up view of an image of the prototypeprosthetic tricuspid valve 5600 clamping onto a sheet of paper orientedapproximately perpendicular (e.g., 90° +/−45°) to the central axis ofthe elongate central passageway 104 of the prosthetic tricuspid valve5600, in accordance with an embodiment. FIG. 56 is a side view of animage of the prototype prosthetic tricuspid valve 5600 clamping onto asheet of paper oriented approximately perpendicular (e.g., 90° +/−45°)to the central axis of the elongate central passageway 104 of theprosthetic tricuspid valve 5600, in accordance with an embodiment.

FIG. 57 is a bottom-up view of an image of a prototype prosthetictricuspid valve 5700, in accordance with an embodiment. In theembodiment of the prosthetic tricuspid valve 5700 depicted in FIG. 57,two of the ventricular arms differ from the ventricular arms 106-2described throughout this disclosure. Specifically, in the embodiment ofthe prosthetic tricuspid valve 5700 depicted in FIG. 57,ventricular-directed arms 5701 are ventricular arms that have beenaltered to differ from the ventricular arms 106-2 described throughoutthis disclosure. In particular, the distal segment 110 of eachventricular-directed arm 5701 has been altered to extend toward theventricular end 120 of the cylindrical portion 116 of the at least onesupport structure 102. This extension of the distal segment 110 of eachventricular-directed arm 5701 toward the ventricular end 120 of thecylindrical portion 116 of the at least one support structure 102enables the distal segment 110 of each ventricular-directed arm 5701 tocontact a native leaflet of a native tricuspid valve on an atrial sideof the native tricuspid valve, rather than on a ventricular side of thenative tricuspid valve, thereby holding the native leaflet radiallyoutward from the native tricuspid valve in an open position.

Configuring the ventricular-directed arms 5701 to hold a native leafletradially outward from a native tricuspid valve in an open position canbe useful in many different embodiments. For example, configuring theventricular-directed arms 5701 to hold a native leaflet radially outwardfrom a native tricuspid valve in an open position can be useful inembodiments in which the native leaflet is difficult to capture by thearms 106 for one reason or another (e.g., if the native leaflet is toosmall or restricted). As another example, configuring theventricular-directed arms 5701 to hold a native leaflet radially outwardfrom a native tricuspid valve in an open position can be useful inminimizing a number of echocardiography planes and/or viewpointsrequired during implantation of the prosthetic tricuspid valve (therebysimplifying the implantation procedure). In such embodiments, ratherthan attempt to capture all three native leaflets of the nativetricuspid valve, one or more native leaflets can be pushed aside asdescribed above, and the remaining native leaflets can be captured bythe arms 106. While the prosthetic tricuspid valve 5700 includes twoventricular-directed arms 5701, in alternative embodiments, theprosthetic tricuspid valve 5700 can include any quantity ofventricular-directed arms 5701, such as, for example, zero, one, two,three, or more than three ventricular-directed arms 5701.

FIG. 58 illustrates a CAD drawing of a tilted side view of theprosthetic tricuspid valve 5800 having three support structures 102-1,102-2, and 102-3, in accordance with an embodiment. The prosthetictricuspid valve 5800 is similar to the prosthetic tricuspid valve 5200depicted in FIGS. 52, 53, and 55. However, the prosthetic tricuspidvalve 5800 includes two ventricular-directed arms 5701, as describedabove with regard to FIG. 57. Like the ventricular arms 106-2, theventricular-directed arms 5701 are formed from the second supportstructure 102-2.

FIG. 59 illustrates a view of a flattened support structure 102 of aprosthetic tricuspid valve, in accordance with an embodiment. As shownin FIG. 59, the support structure 102 includes an atrial end 118 and aventricular end 120. A plurality of interlocking mechanisms 5900 areincluded at the atrial end 118 of the support structure 102. Asdiscussed below with regard to FIG. 59, each interlocking mechanism 5900of the support structure 102 is configured to interlock with acorresponding interlocking mechanism 3600 of a spreader arm 2300.

FIG. 60 illustrates loading, locking, and releasing of interlockingmechanisms 5900 of a support structure 102 of a prosthetic tricuspidvalve, in accordance with an embodiment. Specifically, as shown in FIG.60, each interlocking mechanism 5900 of the support structure 102 isinterlocked with a corresponding interlocking mechanism 3600 of aspreader arm 2300.

Loading, locking, and releasing of the interlocking mechanisms 5900 ofthe support structure 102 is accomplished using an extension 3602 ofeach interlocking mechanism 3600 of each spreader arm 2300.Specifically, during loading of the interlocking mechanism 5900 of thesupport structure 102 with the corresponding interlocking mechanism 3600of the spreader arm 2300, the extension 3602 of the interlockingmechanism 3600 of the spreader arm 2300 is partially retracted from theinterlocking mechanism 5900 of the support structure 102, therebypushing the interlocking mechanism 3600 of the spreader arm 2300 to theside and enabling the interlocking mechanism 5900 of the supportstructure 102 to snap into a locked position with the interlockingmechanism 3600 of the spreader arm 2300. During locking of theinterlocking mechanism 5900 of the support structure 102 with thecorresponding interlocking mechanism 3600 of the spreader arm 2300, theextension 3602 of the interlocking mechanism 3600 of the spreader arm2300 is advanced fully over the interlocking mechanism 5900 of thesupport structure 102, thereby locking the interlocking mechanism 3600of the spreader arm 2300 and the interlocking mechanism 5900 of thesupport structure 102 into the locked position. During releasing of theinterlocking mechanism 5900 of the support structure 102 from thecorresponding interlocking mechanism 3600 of the spreader arm 2300, theextension 3602 of the interlocking mechanism 3600 of the spreader arm2300 is fully retracted from the interlocking mechanism 5900 of thesupport structure 102, thereby enabling the interlocking mechanism 5900of the support structure 102 to expand and to release from the lockedposition with the interlocking mechanism 3600 of the spreader arm 2300.

FIG. 61 illustrates a view of a flattened support structure 102configured to form ventricular arms 106-2 of a prosthetic tricuspidvalve, in accordance with an embodiment.

FIG. 62A is an image of a prototype support structure 102 formingventricular arms 106-2 of a prosthetic tricuspid valve, in accordancewith an embodiment.

FIG. 62B is an image of a prototype support structure 102 formingventricular arms 106-2 and ventricular-directed arms 5701 of aprosthetic tricuspid valve, in accordance with an embodiment.

FIGS. 63A-B illustrate CAD drawings of a support structure 102 formingventricular arms 106-2 of a prosthetic tricuspid valve, in accordancewith an embodiment. Specifically, FIG. 63A illustrates a top-down viewof a CAD drawing of a support structure 102 forming ventricular arms106-2 of a prosthetic tricuspid valve, in accordance with an embodiment.FIG. 63B illustrates a side view of a CAD drawing of a support structure102 forming ventricular arms 106-2 of a prosthetic tricuspid valve, inaccordance with an embodiment.

FIGS. 64A-B illustrate CAD drawings of a support structure 102 formingventricular arms 106-2 and ventricular-directed arms 5701 of aprosthetic tricuspid valve, in accordance with an embodiment.Specifically, FIG. 64A illustrates a top-down view of a CAD drawing of asupport structure 102 forming ventricular arms 106-2 andventricular-directed arms 5701 of a prosthetic tricuspid valve, inaccordance with an embodiment. FIG. 64B illustrates a side view of a CADdrawing of a support structure 102 forming ventricular arms 106-2 andventricular-directed arms 5701 of a prosthetic tricuspid valve, inaccordance with an embodiment.

FIG. 65 illustrates a view of a flattened support structure 102configured to form atrial arms 106-1 of a prosthetic tricuspid valve, inaccordance with an embodiment. As shown in FIG. 65, the tip 142 of eachatrial arm 106-1 can include a locking mechanism 6500. Each lockingmechanism 6500 of the support structure 102 is configured to lock in acorresponding restraint 410 (e.g., a suture).

During loading of the locking mechanisms 6500, a narrow opening 6501 ofeach locking mechanism 6500 enables the corresponding restraint 410enter the locking mechanism 6500 and to lock into place. During lockingof the locking mechanisms 6500, a tooth 6502 of each locking mechanism6500 prevents the corresponding locked restraint 410 from exiting thelocking mechanism 6500 via the narrow opening 6501 while the restraint410 is under tension. During release of the locking mechanisms 6500,when tension is removed from the restraint 410, the restraint 410 ispermitted to exit the locking mechanism 6500 via the narrow opening6501.

FIG. 66 illustrates a CAD drawing of a side view of the prosthetictricuspid valve 5800, in accordance with an embodiment. As also shown inFIG. 66, the distal segment 114 of each atrial arm 106-1 extends fromthe atrial end 118 of the cylindrical portion 116 of the supportstructures 102-1, 102-2, and 102-3, but extends toward the ventricularend 120 of the cylindrical portion 116 of the support structures 102-1,102-2, and 102-3. Conversely, the distal segment 110 of each ventriculararm 106-2 extends from the ventricular end 120 of the cylindricalportion 116 of the support structures 102-1, 102-2, and 102-3, butextends toward the atrial end 118 of the cylindrical portion 116 of thesupport structures 102-1, 102-2, and 102-3. As a result, as discussedabove, overbite occurs between the atrial arms 106-1 and the ventriculararms 106-2. The dotted line across the prosthetic tricuspid valve 5800in FIG. 66 depicts points of overbite between the atrial arms 106-1 andthe ventricular arms 106-2. As shown in FIG. 66, the overbite betweenthe atrial arms 106-1 and the ventricular arms 106-2 enables the atrialarms 106-1 and the ventricular arms 106-2 to clamp a native leaflet500-2 of a native tricuspid valve between them. Conversely, as shown inFIG. 66, the ventricular-directed arm 5701 is configured to hold anative leaflet 500-1 radially outward from a native tricuspid valve inan open position.

Additionally, as shown in FIG. 66, the tip 142 of each atrial arm 106-1includes an extended segment 2400 with a third bend toward the atrialend 118 of the cylindrical portion 116 of the support structures 102-1,102-2, and 102-3 for more atraumatic engagement of the atrial surfacesof the native leaflets. Similarly, as shown in FIG. 66, the tip 140 ofthe ventricular-directed arm 5701 can include an extended segment with athird bend toward the ventricular end 120 of the cylindrical portion 116of the support structures 102-1, 102-2, and 102-3 for more atraumaticengagement of the atrial surface of the native leaflet 500-1. Thesethird bends of the atrial arms 106-1 and the ventricular-directed arm5701 can also prevent the atrial arms 106-1 and the ventricular-directedarm 5701 from embedding within tissue of the native leaflets.

FIGS. 67A-C illustrate side views of overbite between an atrial arm106-1 and a ventricular arm 106-2 of a prosthetic tricuspid valve, inaccordance with an embodiment. Specifically, FIGS. 67A-C illustrate sideviews of varying amounts of overbite between the atrial arm 106-1 andthe ventricular arm 106-2 of the prosthetic tricuspid valve, inaccordance with an embodiment. The amount of overbite between the atrialarm 106-1 and the ventricular arm 106-2 of the prosthetic tricuspidvalve determines the magnitude of the clamping force of the arms 106 ona native leaflet of a native tricuspid valve. Furthermore, the magnitudeof the clamping force of the arms 106 on the native leaflet of thenative tricuspid valve determines the amount of biodynamic movement ofthe prosthetic tricuspid valve within the native tricuspid valvethroughout cardiac cycles of the heart.

FIG. 67A illustrates a side view of a relatively small amount ofoverbite between the atrial arm 106-1 and the ventricular arm 106-2 ofthe prosthetic tricuspid valve, in accordance with an embodiment. As aresult of this relatively small amount of overbite between the atrialarm 106-1 and the ventricular arm 106-2 of the prosthetic tricuspidvalve in FIG. 67A, a relatively small amount of tension can be exertedon a native leaflet clamped between the atrial arm 106-1 and theventricular arm 106-2. Furthermore, as a result of this relatively smallamount of tension exerted on the native leaflet clamped between theatrial arm 106-1 and the ventricular arm 106-2, the prosthetic tricuspidvalve is able to demonstrate a relatively large amount of biodynamicmovement within the native tricuspid valve throughout cardiac cycles ofthe heart.

FIG. 67B illustrates a side view of a relatively moderate amount ofoverbite between the atrial arm 106-1 and the ventricular arm 106-2 ofthe prosthetic tricuspid valve, in accordance with an embodiment. As aresult of this relatively moderate amount of overbite between the atrialarm 106-1 and the ventricular arm 106-2 of the prosthetic tricuspidvalve in FIG. 67B, a relatively moderate amount of tension can beexerted on a native leaflet clamped between the atrial arm 106-1 and theventricular arm 106-2. Furthermore, as a result of this relativelymoderate amount of tension exerted on the native leaflet clamped betweenthe atrial arm 106-1 and the ventricular arm 106-2, the prosthetictricuspid valve is able to demonstrate a relatively moderate amount ofbiodynamic movement within the native tricuspid valve throughout cardiaccycles of the heart.

FIG. 67C illustrates a side view of a relatively large amount ofoverbite between the atrial arm 106-1 and the ventricular arm 106-2 ofthe prosthetic tricuspid valve, in accordance with an embodiment. As aresult of this relatively large amount of overbite between the atrialarm 106-1 and the ventricular arm 106-2 of the prosthetic tricuspidvalve in FIG. 67C, a relatively large amount of tension can be exertedon a native leaflet clamped between the atrial arm 106-1 and theventricular arm 106-2. Furthermore, as a result of this relatively largeamount of tension exerted on the native leaflet clamped between theatrial arm 106-1 and the ventricular arm 106-2, the prosthetic tricuspidvalve is able to demonstrate a relatively small amount of biodynamicmovement within the native tricuspid valve throughout cardiac cycles ofthe heart.

FIGS. 68A-B illustrate different implementations of the atrial sealingskirt 204, in accordance with an embodiment. Specifically, FIG. 68Aillustrates a symmetric implementation of the atrial sealing skirt 204,in accordance with an embodiment. FIG. 68B illustrates an asymmetricimplementation of the atrial sealing skirt 204, in accordance with anembodiment.

The symmetric atrial sealing skirt 204 depicted in FIG. 68A can be usedfor symmetric prosthetic tricuspid devices, such as the prosthetictricuspid devices depicted in FIGS. 62A and 64A-B. Specifically, thesymmetric atrial sealing skirt 204 depicted in FIG. 68A can be used forprosthetic tricuspid devices having symmetrical ventricular arms (e.g.,only ventricular arms 106-2).

Conversely, the asymmetric atrial sealing skirt 204 depicted in FIG. 68Bcan be used for asymmetric prosthetic tricuspid devices, such as theprosthetic tricuspid devices depicted in FIGS. 62B and 65A-B.Specifically, the asymmetric atrial sealing skirt 204 depicted in FIG.68B can be used for prosthetic tricuspid devices having asymmetricalventricular arms (e.g., ventricular arms 106-2 and ventricular-directedarm(s) 5701).

Tabs of the atrial sealing skirt 204 that line the elongate centralpassageway 104 can be folded down to join another portion of the cover200 that runs along an inside of the cylindrical portion 116 of at leastone support structure 102 of the prosthetic tricuspid valve. Thefenestrations 300 of the atrial sealing skirt 204 can allow space forventricular arms 106-2 to pass through the atrial sealing skirt 204during assembly of the prosthetic tricuspid valve, such that theventricular arms 106-2 are located exterior to the elongate centralpassageway 104 of the prosthetic tricuspid valve once the prosthetictricuspid valve is assembled. In some embodiments, the asymmetricportion of the asymmetric atrial sealing skirt 204 of FIG. 68B can alsoinclude additional fenestrations 300 to be positioned within a nativeannulus of a native tricuspid valve when the prosthetic tricuspid valveis implanted in the native tricuspid valve.

FIG. 69A-B are images of support structures 102-2 and 102-3 of aprototype prosthetic tricuspid valve 6900, in accordance with anembodiment. Specifically, FIG. 69A is an image of a bottom-up view ofsupport structures 102-2 and 102-3 of the prototype prosthetic tricuspidvalve 6900, in accordance with an embodiment. FIG. 69B is an image of aside view of support structures 102-2 and 102-3 of the prototypeprosthetic tricuspid valve 6900, in accordance with an embodiment.

The prosthetic tricuspid valve 6900 is similar to the prototypeprosthetic tricuspid valve 5600 of FIGS. 56A-C and includes threesupport structures 102-1, 102-2, and 102-3 (shown in FIG. 74). However,the images in FIGS. 69A-B depict only the support structures 102-2 and102-3 of the prototype prosthetic tricuspid valve 6900. As discussedbelow, the first support structure 102-1 does not form the atrial arms106-1 or the ventricular arms 106-2. The second support structure 102-2forms the ventricular arms 106-2, and the third support structure 102-3forms the atrial arms 106-1. As shown in FIGS. 69A-B, the symmetricatrial sealing skirt 204 of FIG. 68A covers the support structures 102-2and 102-3 of the symmetric prototype prosthetic tricuspid valve 6900.

FIG. 70A-B are images of support structures 102-2 and 102-3 of aprototype prosthetic tricuspid valve 7000, in accordance with anembodiment. Specifically, FIG. 70A is an image of a bottom-up view ofsupport structures 102-2 and 102-3 of the prototype prosthetic tricuspidvalve 7000, in accordance with an embodiment. FIG. 70B is an image of aside view of support structures 102-2 and 102-3 of the prototypeprosthetic tricuspid valve 7000, in accordance with an embodiment.

The prototype prosthetic tricuspid valve 7000 is similar to theprototype prosthetic tricuspid valve 5700 of FIG. 57 and includes threesupport structures 102-1, 102-2, and 102-3. However, the images in FIGS.70A-B depict only the support structures 102-2 and 102-3 of theprototype prosthetic tricuspid valve 7000. As shown in FIGS. 70A-B, theasymmetric atrial sealing skirt 204 of FIG. 68B covers the supportstructures 102-2 and 102-3 of the symmetric prototype prosthetictricuspid valve 7000.

FIG. 71 is an image of a top-down view of support structure 102-3 of theprototype prosthetic tricuspid valve 6900, in accordance with anembodiment. As shown in FIG. 71, the atrial sealing skirt 204 of thesupport structure 102-3 of prosthetic tricuspid valve 6900 includesfenestrations 300 configured to allow ventricular arms 106-2 to passthrough the atrial sealing skirt 204 during assembly of the prosthetictricuspid valve 6900, such that the ventricular arms 106-2 are locatedexterior to the elongate central passageway 104 of the prosthetictricuspid valve 6900 once the prosthetic tricuspid valve 6900 isassembled.

FIGS. 72A-B are images of support structures 102-2 and 102-3 of theprototype prosthetic tricuspid valve 6900, in accordance with anembodiment. Specifically, FIG. 72A is an image of a top-down view ofsupport structures 102-2 and 102-3 of the prototype prosthetic tricuspidvalve 6900, in accordance with an embodiment. FIG. 72B is an image of aside view of support structures 102-2 and 102-3 of the prototypeprosthetic tricuspid valve 6900, in accordance with an embodiment.

As discussed above with regard to FIGS. 69A-B, the prosthetic tricuspidvalve 6900 includes three support structures 102-1, 102-2, and 102-3(shown in FIG. 74). However, the images in FIGS. 72A-B depict only thesupport structures 102-2 and 102-3 of the prototype prosthetic tricuspidvalve 6900. As discussed below, the first support structure 102-1 doesnot form the atrial arms 106-1 or the ventricular arms 106-2. The secondsupport structure 102-2 forms the ventricular arms 106-2, and the thirdsupport structure 102-3 forms the atrial arms 106-1.

The three support structures 102-1, 102-2, and 102-3 are configured tofit together to form the prosthetic tricuspid valve 6900. Specifically,to fit the three support structures 102-1, 102-2, and 102-3 together toform the prosthetic tricuspid valve 6900, a radius of curvature of asecondary bend 130 of each atrial arm 106-1 is received by a V-shapedstrut 2200-1 of the first support structure 102-1 (shown in FIG. 74).Additionally, to fit the three support structures 102-1, 102-2, and102-3 together to form the prosthetic tricuspid valve 6900, a radius ofcurvature of a secondary bend 126 of each ventricular arm 106-2 isreceived by a V-shaped strut 2200-1 of the support structure 102-1(shown in FIG. 74), and also contacts a mirror V-shaped strut 2200-3 ofthe support structure 102-3 that forms the atrial arms 106-1.

Note that while the prosthetic tricuspid valve 6900 is configured toalso include the support structure 102-1 (shown in FIG. 74) in additionto the support structures 102-2 and 102-3, in some embodiments, aprosthetic tricuspid valve does not require three support structures.Rather, in some embodiments, such as the embodiments of prosthetictricuspid valves 4600, 4800, and 5000 a prosthetic tricuspid valve caninclude only two support structures. In such embodiments, there wouldsimply be less reinforcement for the arms 106 of the prosthetictricuspid valve, as described in detail above and below.

FIG. 73 illustrates an atrial sealing skirt 204 including a ventriculararm sleeve 7300 configured to encapsulate a ventricular arm 106-2 of asupport structure 102, in accordance with an embodiment. As shown inFIG. 73, in some embodiments the atrial sealing skirt 204 can includeone or more ventricular arm sleeves 7300, each ventricular arm sleeve7300 configured to encapsulate a corresponding ventricular arm 106-2 ofa support structure 102. Each ventricular arm sleeve 7300 can beconfigured, for example, as a ribbon extending from the atrial sealingskirt 204 covering the support structure 102. To encapsulate aventricular arm 106-2, the ribbon extending from the atrial sealingskirt 204 can be folded over the ventricular arm 106-2, and stitchedclosed around the ventricular arm 106-2.

Encapsulation of a ventricular arm 106-2 by a ventricular arm sleeve7300 can facilitate ingrowth of the ventricular arm 106-2 within anative tricuspid valve leaflet when the prosthetic tricuspid valve isimplanted. Encapsulation of a ventricular arm 106-2 by a ventricular armsleeve 7300 can also provide atraumatic contact between the ventriculararm 106-2 and a native tricuspid valve leaflet when the prosthetictricuspid valve is implanted. Even further, encapsulation of aventricular arm 106-2 by a ventricular arm sleeve 7300 can serve as afailsafe in preventing embolization in the event that the ventriculararm 106-2 fractures when the prosthetic tricuspid valve is implanted.

FIG. 74 is an image of a side view of the prototype prosthetic tricuspidvalve 6900, in accordance with an embodiment. As discussed above withregard to FIGS. 69A-B, the prosthetic tricuspid valve 6900 includesthree support structures 102-1, 102-2, and 102-3. The first supportstructure 102-1 does not form the atrial arms 106-1 or the ventriculararms 106-2. The second support structure 102-2 forms the ventriculararms 106-2, and the third support structure 102-3 forms the atrial arms106-1.

The three support structures 102-1, 102-2, and 102-3 are configured tofit together to form the prosthetic tricuspid valve 6900. Specifically,to fit the three support structures 102-1, 102-2, and 102-3 together toform the prosthetic tricuspid valve 6900, a radius of curvature of asecondary bend 130 of each atrial arm 106-1 is received by a V-shapedstrut 2200-1 of the first support structure 102-1. Additionally, to fitthe three support structures 102-1, 102-2, and 102-3 together to formthe prosthetic tricuspid valve 6900, a radius of curvature of asecondary bend 126 of each ventricular arm 106-2 is received by aV-shaped strut 2200-1 of the support structure 102-1, and also contactsa mirror V-shaped strut 2200-3 of the support structure 102-3 that formsthe atrial arms 106-1.

Additionally, to secure the three support structures 102-1, 102-2, and102-3 to one another to form the prosthetic tricuspid valve 6900, thesupport structures 102-2 and 102-3 are each secured to the supportstructure 102-1. Specifically, as depicted in FIG. 74, to secure thesupport structure 102-3 to the support structure 102-1, an eyelet 3502(shown in FIG. 35) of each atrial arm 106-1 formed by the supportstructure 102-3 is secured to a corresponding eyelet of the supportstructure 102-1. As also depicted in FIG. 74, to secure the supportstructure 102-2 to the support structure 102-1, 3-point nodes of thesupport structure 102-2 are secured to the support structure 102-1.

FIGS. 75-79 illustrate different implementations of prosthetic tricuspidvalves having different numbers of support structures, in accordancewith an embodiment. Specifically, FIGS. 75-79 illustrate differentialload distribution for different implementations of prosthetic tricuspidvalves having different numbers of support structures, in accordancewith an embodiment.

As shown in each of FIGS. 75-79, when prosthetic tricuspid valves areimplanted in a native tricuspid valve throughout cardiac cycles of theheart, atrial-directed forces 7501 are incurred by the ventricular arms106-2 of each prosthetic tricuspid valve as a result of ventricularsystolic pressure loads from the heart. Conversely, ventricular-directedforces 7500 are incurred by the atrial arms 106-1 of each prosthetictricuspid valve as a result of tensioning of native leaflets of thenative tricuspid valve in response to the ventricular systolic pressureloads. As indicated by the magnitude of the arrows of the forces 7500and 7501, the atrial-directed forces 7501 incurred by the ventriculararms 106-2 are much greater in magnitude than the ventricular-directedforces 7500 incurred by the atrial arms 106-1. As a result, and asdiscussed below, distribution of the atrial-directed forces 7501incurred by the ventricular arms 106-2 is more essential to maintainingthe integrity of the prosthetic tricuspid valve than distribution of theventricular-directed forces 7500 are incurred by the atrial arms 106-1.

Depending upon the configuration of the prosthetic tricuspid valve, andparticularly on the number of support structures comprising theprosthetic tricuspid valve, load nodes 7502 and fulcrum points 7503 canbe differentially distributed throughout the prosthetic tricuspid valve,and therefore, the forces 7500 and 7501 can be differentiallydistributed throughout the prosthetic tricuspid valve. Each differentconfiguration of the prosthetic tricuspid valve, and its load nodes 7502and fulcrum points 7503, and therefore its distribution of the forces7500 and 7501, are depicted in FIGS. 75-79.

FIG. 75 illustrates load distribution for the prosthetic tricuspid valve4400 having one support structure 102, in accordance with an embodiment.In the embodiment of the prosthetic tricuspid valve 4400 having onesupport structure 102, both the atrial arms 106-1 and the ventriculararms 106-2 are formed from the one support structure 102.

As shown in FIG. 75, the prosthetic tricuspid valve 4400 has a singleload node 7502 and a single fulcrum point 7503 located in the samegeneral location of the one support structure 102. Additionally, thereare no additional support structures supporting the ventricular arms106-2. Thus, distribution of the atrial-directed forces 7501 incurred bythe ventricular arms 106-2 is minimal, effectively resulting in greaterbreakability of the prosthetic tricuspid valve 4400.

FIG. 76 illustrates load distribution for the prosthetic tricuspid valve4800 having two support structures 102-1 and 102-2, in accordance withan embodiment. In the embodiment of the prosthetic tricuspid valve 4800having two support structures 102-1 and 102-2, the ventricular arms106-2 are formed from the first support structure 102-1 and the atrialarms 106-1 are formed from the second support structure 102-2.

As shown in FIG. 76, the prosthetic tricuspid valve 4800 has one loadnode 7502 located on each of the two support structures 102-1 and 102-2.The two load nodes 7502 are both located in the same general location ofa single fulcrum point 7503. Additionally, the support structure 102-1supports the atrial arms 106-1 formed by the support structure 102-2,rather than the ventricular arms 1061-2. Thus the majority of theimproved load distribution in the prosthetic tricuspid valve 4800 occursin the atrial arms 106-1, which is less important because the atrialarms 106-1 experience less force than the ventricular arms 106-2 whenthe prosthetic tricuspid valve 4800 is implanted in vivo as discussedabove. Distribution of the atrial-directed forces 7501 incurred by theventricular arms 106-2 is not improved relative to the prosthetictricuspid valve 4400.

FIG. 77 illustrates load distribution for the prosthetic tricuspid valve5000 having two support structures 102-1 and 102-2, in accordance withan embodiment. In the embodiment of the prosthetic tricuspid valve 5000having two support structures 102-1 and 102-2, the first supportstructure 102-1 does not form the atrial arms 106-1 or the ventriculararms 106-2. The second support structure 102-2 forms both the atrialarms 106-1 and the atrial arms 106-1.

As shown in FIG. 77, the prosthetic tricuspid valve 5000 has one loadnode 7502 located on each of the two support structures 102-1 and 102-2.The two load nodes 7502 are both located in the same general location ofa single fulcrum point 7503. However, unlike the prosthetic tricuspidvalve 4800, distribution of the atrial-directed forces 7501 incurred bythe ventricular arms 106-2 is improved relative to the prosthetictricuspid valves 4400 because the support structure 102-1 providesadditional support to the ventricular arms 106-2 formed by the supportstructure 102-2. The support structure 102-1 also provides additionalsupport to the atrial arms 106-1 formed by the support structure 102-2.

FIG. 78 illustrates load distribution for the prosthetic tricuspid valve4600 having two support structures 102-1 and 102-2, in accordance withan embodiment. In the embodiment of the prosthetic tricuspid valve 4600having two support structures 102-1 and 102-2, the atrial arms 106-1 areformed from the first support structure 102-1 and the ventricular arms106-2 are formed from the second support structure 102-2.

As shown in FIG. 78, the prosthetic tricuspid valve 4600 has one loadnode 7502 located on each of the two support structures 102-1 and 102-2.However, unlike the prosthetic tricuspid valves 4800 and 5000, the twoload nodes 7502 are not located in the same general location. A singlefulcrum point 7503 is located in the same general location of only oneof the two load nodes 7502. Additionally, the support structure 102-1provides additional support to the ventricular arms 106-2 formed by thesupport structure 102-2. As a result, distribution of theatrial-directed forces 7501 incurred by the ventricular arms 106-2 andof the ventricular-directed forces 7500 incurred by the atrial arms106-1 is improved relative to the prosthetic tricuspid valves 4400,4800, and 5000.

FIG. 79 illustrates load distribution for the prosthetic tricuspid valve5200 having three support structures 102-1, 102-2, and 102-3, inaccordance with an embodiment. In the embodiment of the prosthetictricuspid valve 5200 having three support structures 102-1, 102-2, and102-3, the first support structure 102-1 does not form the atrial arms106-1 or the ventricular arms 106-2. The second support structure 102-2forms the ventricular arms 106-2. The third support structure 102-3forms the atrial arms 106-1.

As shown in FIG. 79, the prosthetic tricuspid valve 5200 has one loadnode 7502 located on each of the three support structures 102-1, 102-2,and 102-3. The three load nodes 7502 are not located in the same generallocation of a single fulcrum point 7503. Additionally, the first supportstructure 102-1 can provide additional reinforcement to the atrial arms106-1 formed from the third support structure 102-3, and the firstsupport structure 102-1 and the third support structure 102-3 can bothprovide additional reinforcement to the ventricular arms 106-2 formedfrom the second support structure 102-2. As a result, distribution ofthe atrial-directed forces 7501 incurred by the ventricular arms 106-2and of the ventricular-directed forces 7500 incurred by the atrial arms106-1 is most improved in the prosthetic tricuspid valve 5200, relativeto the prosthetic tricuspid valves 4400, 4800, 5000, and 4600.

FIG. 80 illustrates a CAD drawing of a cut-away side view of theprosthetic tricuspid valve 5200, in accordance with an embodiment. Acentral axis 8000 of the elongate central passageway 104 of thecylindrical portion 116 of at least one of the three support structures102-1, 102-2, and 102-3 is shown in FIG. 80.

As discussed in detail above, the distal segment of each arm 106 (e.g.,the distal segment 114 of each atrial arm 106-1 and the distal segment110 of each ventricular arm 106-2) extends perpendicularly away from thecentral axis 8000 of the elongate central passageway 104 for attachmentof the prosthetic tricuspid valve 5200 to an object (e.g., a nativetricuspid valve leaflet). As referred to herein, a distal segment of anarm 106 extending “perpendicularly” away from the central axis 8000 ofthe elongate central passageway 104 refers to the distal segment of thearm 106 extending away from the central axis 8000 of the elongatecentral passageway 104 such that that a line 8001 drawn from a point ofcontact 8002 of the distal segment of the arm 106 with an object (e.g.,a native tricuspid valve leaflet) to a longitudinal position 8003 alongthe exterior surface 147 of the cylindrical portion 116 of at least oneof the three support structures 102-1, 102-2, and 102-3 from which thedistal segment extends, is oriented approximately 90° +/−45° from thecentral axis 8000 of the elongate central passageway 104. In someembodiments, the point of contact 8002 of a distal segment of an arm 106can be the tip 140 or 142 of the arm 106. In alternative embodiments inwhich a distal segment of an arm 106 includes an extended segment havinga third bend, the point of contact 8002 of the distal segment of the arm106 can be the extended segment, or more particularly, the third bend,of the arm 106. The point of contact 8002 of a distal segment of an arm106 can also be any other portion of the distal segment of the arm 106.As discussed in further detail below, this approximate perpendicularityof the line 8001 from the point of contact 8002 of the distal segment tothe longitudinal position 8003 along the exterior surface 147 of thecylindrical portion 116 from which the distal segment extends enablesaxial stabilization of the prosthetic tricuspid valve 5200 within thenative tricuspid valve.

It is understood that any specific order or hierarchy of blocks in theprocesses disclosed is an illustration of example approaches. Based uponimplementation preferences, it is understood that the specific order orhierarchy of blocks in the processes may be rearranged, or that not allillustrated blocks be performed. Any of the blocks may be performedsimultaneously. In one or more embodiments, multitasking and parallelprocessing may be advantageous. Moreover, the separation of varioussystem components in the embodiments described above should not beunderstood as requiring such separation in all embodiments, and itshould be understood that the described program components and systemscan generally be integrated together in a single software product orpackaged into multiple software products.

The subject technology is illustrated, for example, according to variousaspects described above. The present disclosure is provided to enableany person skilled in the art to practice the various aspects describedherein. The disclosure provides various examples of the subjecttechnology, and the subject technology is not limited to these examples.Various modifications to these aspects will be readily apparent to thoseskilled in the art, and the generic principles defined herein may beapplied to other aspects.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically so stated, but rather “one or more.”Unless specifically stated otherwise, the term “some” refers to one ormore. Pronouns in the masculine (e.g., his) include the feminine andneuter gender (e.g., her and its) and vice versa. Headings andsubheadings, if any, are used for convenience only and do not limit theinvention.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs. In one aspect, various alternative configurationsand operations described herein may be considered to be at leastequivalent.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “or” to separate any of the items, modifies thelist as a whole, rather than each item of the list. The phrase “at leastone of” does not require selection of at least one item; rather, thephrase allows a meaning that includes at least one of any one of theitems, and/or at least one of any combination of the items, and/or atleast one of each of the items. By way of example, the phrase “at leastone of A, B, or C” may refer to: only A, only B, or only C; or anycombination of A, B, and C.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples. A phrase such as an aspectmay refer to one or more aspects and vice versa. A phrase such as an“embodiment” does not imply that such embodiment is essential to thesubject technology or that such embodiment applies to all configurationsof the subject technology. A disclosure relating to an embodiment mayapply to all embodiments, or one or more embodiments. An embodiment mayprovide one or more examples. A phrase such an embodiment may refer toone or more embodiments and vice versa. A phrase such as a“configuration” does not imply that such configuration is essential tothe subject technology or that such configuration applies to allconfigurations of the subject technology. A disclosure relating to aconfiguration may apply to all configurations, or one or moreconfigurations. A configuration may provide one or more examples. Aphrase such a configuration may refer to one or more configurations andvice versa.

In one aspect, unless otherwise stated, all measurements, values,ratings, positions, magnitudes, sizes, and other specifications that areset forth in this specification, including in the claims that follow,are approximate, not exact. In one aspect, they are intended to have areasonable range that is consistent with the functions to which theyrelate and with what is customary in the art to which they pertain.

It is understood that some or all steps, operations, or processes may beperformed automatically, without the intervention of a user. Methodclaims may be provided to present elements of the various steps,operations or processes in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe appended claims. Moreover, nothing disclosed herein is intended tobe dedicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claims element is to be construedunder the provisions of 35 U.S.C. § 112 (f) unless the element isexpressly recited using the phrase “means for” or, in the case of amethod, the element is recited using the phrase “step for.” Furthermore,to the extent that the term “include,” “have,” or the like is used, suchterm is intended to be inclusive in a manner similar to the term“comprise” as “comprise” is interpreted when employed as a transitionalword in a claim.

The Title, Background, Brief Description of the Drawings, and Claims ofthe disclosure are hereby incorporated into the disclosure and areprovided as illustrative examples of the disclosure, not as restrictivedescriptions. It is submitted with the understanding that they will notbe used to limit the scope or meaning of the claims. In addition, in theDetailed Description, it can be seen that the description providesillustrative examples and the various features are grouped together invarious embodiments for the purpose of streamlining the disclosure. Thismethod of disclosure is not to be interpreted as reflecting an intentionthat the claimed subject matter requires more features than areexpressly recited in any claim. Rather, as the following claims sreflect, inventive subject matter lies in less than all features of asingle disclosed configuration or operation. The following claims arehereby incorporated into the Detailed Description, with each claimsstanding on its own to represent separately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but are to be accorded the full scope consistent with thelanguage of the claims and to encompass all legal equivalents.Notwithstanding, none of the claims are intended to embrace subjectmatter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or103, nor should they be interpreted in such a way.

Due to claim count limitations, the following subject matter has notbeen included in the claims below, but for clarity has been drafted inclaim form, with reference to the below claims.

Claim A: The prosthetic heart valve of claim 1, wherein the at least onesupport structure is configured to biodynamically fix the prostheticheart valve to the native leaflets such that the at least one supportstructure is moveable within a native annulus of the native heart valveresponsive to changes in pressure on one or more sides of the nativeheart valve.

Claim B: The prosthetic heart valve of claim 11, wherein, in animplanted configuration in which the at least one support structurebiodynamically fixes the prosthetic heart valve to the native leafletsof the native heart valve, the fenestration feature is disposed betweenthe elongate central passageway and a native annulus of the native heartvalve.

Claim C: The prosthetic heart valve of claim 10, wherein: the atrial setof arms is attached to the ventricular end of the cylindrical portion ofthe at least one support structure, the ventricular set of arms isattached to the atrial end of the cylindrical portion of the at leastone support structure, and the one or more covers initiate at and areattached to the distal segment of each arm of the atrial set of arms,extend to and are attached to the proximal segment of each arm of theventricular set of arms, extend through the cylindrical portion of theat least one support structure within the elongate central passageway,and extend around the cylindrical portion of the at least one supportstructure to attach to the proximal segment of each of the atrial set ofarms.

Claim D: The prosthetic heart valve of claim C, wherein the one or morecovers terminate at and attach to a location along the proximal segmentof each arm of the atrial set of arms that is a common distance from thecylindrical portion of the at least one support structure.

Claim E: The prosthetic heart valve of claim C, wherein the one or morecovers further extend and attach to the distal segment of each arm ofthe ventricular set of arms.

Claim F: The prosthetic heart valve of claim 23, wherein the one or moresupport structures comprise two support structures.

Claim G: The prosthetic heart valve of claim 23, wherein the one or moresupport structures comprise three support structures.

Claim H: A prosthetic heart valve, comprising: one or more supportstructures that define an elongate central passageway; and a valvestructure attached to at least one support structure and disposed withinthe elongate central passageway for control of blood flow through theelongate central passageway, wherein at least one support structurecomprises a plurality of arms that extend away from the elongate centralpassageway for attachment of the at least one support structure tonative leaflets of a native heart valve of a heart.

Claim I: The prosthetic heart valve of claim H, wherein the plurality ofarms include: an atrial set of arms that extend from an atrial end of atleast one support structure before curving to extend away from theelongate central passageway; and a ventricular set of arms that extendfrom a ventricular end of at least one support structure before curvingto extend away from the elongate central passageway.

Claim J: The prosthetic heart valve of claim I, wherein the atrial armsand the ventricular arms are configured to cooperate to hold the nativeleaflets of the native heart valve to maintain the elongate centralpassageway in a native annulus of the native heart valve without anydirect attachment to the native annulus or to native cords associatedwith the native heart valve.

Claim K: A prosthetic heart valve, comprising: one or more supportstructures that define an elongate central passageway; and a pluralityof leaflet elements attached to at least one support structure anddisposed within the elongate central passageway, wherein at least onesupport structure is configured to biodynamically fix the prostheticheart valve within, and separated from, a native annulus of a nativeheart valve of a heart.

Claim L: The prosthetic heart valve of claim K, wherein at least onesupport structure of the one or more support structures comprises acylindrical portion comprising an atrial end and a ventricular end, theelongate central passageway is defined by the cylindrical portion of theat least one support structure, and the cylindrical portion of the atleast one support structure is expandable to a maximum radial width thatis less than a minimum radial width of the native annulus of the nativeheart valve.

Claim M: The prosthetic heart valve of claim K, wherein at least onesupport structure is configured to biodynamically fix the prostheticheart valve within, and separated from, the native annulus of the nativeheart valve by grasping native leaflets of the native heart valve,without direct attachment to the native annulus or native cordsassociated with the native heart valve.

Claim N: The prosthetic heart valve of claim K, wherein the native heartvalve is the tricuspid valve.

Claim O: The method of claim 26, further comprising detaching theplurality of restraints from the atrial plurality of arms.

Claim P: The method of claims 28 and/or 30, wherein the plurality ofspreader arms extend from a mid layer within the sheath.

Claim Q: The method of claim P, wherein each restraint of the pluralityof restraints extends from the sheath between a pair of the plurality ofspreader arms.

Claim R: The method of claim 28, 30, P, and/or Q, wherein each spreaderarm of the plurality of spreader arms includes an interlocking mechanismthat maintains contact with the atrial end of the cylindrical portion ofthe at least one support structure.

1. A prosthetic heart valve, comprising: a support structure, whereinthe support structure defines an elongate central passageway; and aplurality of leaflet elements attached to the support structure anddisposed within the elongate central passageway for control of bloodflow through the elongate central passageway, wherein the supportstructure is configured to biodynamically fix the prosthetic heart valveto native leaflets of a native heart valve of a heart, wherein thesupport structure is not directly attached to the native annulus of thenative heart valve, wherein the support structure comprises an atrialset of arms and a ventricular set of arms, and wherein: in the event ofmotion of the cylindrical portion of the support structure toward theatrial side of the native heart valve due to a ventricular systolicpressure load, the ventricular set of arms resist the motion while theatrial set of arms relax to maintain contact with the atrial side of thenative leaflets, and/or in the event of motion of the cylindricalportion of the support structure toward the ventricular side of thenative heart valve due to a ventricular diastoleic pressure load and/oran elimination of a previously applied ventricular systolic load, theatrial set of arms resist the motion while the ventricular set of armsrelax to maintain contact with the ventricular side of the nativeleaflets.
 2. The prosthetic heart valve of claim 1, wherein: the supportstructure comprises a cylindrical portion comprising an atrial end and aventricular end, the elongate central passageway is defined by thecylindrical portion of the support structure, each arm of the atrial setof arms and the ventricular set of arms comprises a proximal segmentthat is proximal to the cylindrical portion of the support structure anda distal segment that is distal to the cylindrical portion of thesupport structure, the atrial set of arms is configured to contact thenative leaflets on an atrial side of the native heart valve, and/or theventricular set of arms is configured to contact the native leaflets ona ventricular side of the native heart valve.
 3. (canceled)
 4. Theprosthetic heart valve of claim 2, wherein the arms of the atrial set ofarms alternate with the arms of the ventricular set of arms around acircumference of the cylindrical portion of the support structure,and/or wherein the arms of the atrial set of arms and the arms of theventricular set of arms extend across a cross-sectional plane of thecylindrical portion of the support structure.
 5. The prosthetic heartvalve of claim 2, wherein: the distal segments of the arms of the atrialset of arms extend toward the ventricular end of the cylindrical portionof the support structure, thereby enabling the distal segments of thearms of the atrial set of arms to clamp the native leaflets on theatrial side of the native heart valve; and the distal segments of thearms of the ventricular set of arms extend toward the atrial end of thecylindrical portion of the support structure, thereby enabling thedistal segments of the arms of the ventricular set of arms to clamp thenative leaflets on the ventricular side of the native heart valve. 6.The prosthetic heart valve of claim 2, wherein: the distal segments ofthe arms of the atrial set of arms each have a tip that curves towardthe atrial end of the cylindrical portion of the support structure,thereby reducing trauma to the native leaflets on the atrial side of thenative heart valve at the points of contact of the atrial set of arms;and the distal segments of the arms of the ventricular set of arms eachhave a tip that curves toward the ventricular end of the cylindricalportion of the support structure, thereby reducing trauma to the nativeleaflets on the ventricular side of the native heart valve at the pointsof contact of the ventricular set of arms.
 7. The prosthetic heart valveof claim 2, wherein the cylindrical portion of the support structure isradially collapsible for transcatheter implantation.
 8. The prostheticheart valve of claim 2, wherein the distal segments of the atrial andventricular sets of arms extend perpendicularly away from the centralaxis of the elongate central passageway and/or are resilientlystraightenable.
 9. The prosthetic heart valve of claim 2, wherein thedistal segments of the one or more arms of the ventricular set of armsextend toward the ventricular end of the cylindrical portion of thesupport structure, thereby enabling the distal segments of the one ormore arms of the ventricular set of arms to contact one of the nativeleaflets on the atrial side of the native heart valve rather than on theventricular side of the native heart valve, thereby holding the nativeleaflet radially outward from the native heart valve in an openposition.
 10. The prosthetic heart valve of claim 2, further comprisingone or more covers that extend within the elongate central passagewayand over one or more of the atrial set of arms and/or the ventricularset of arms.
 11. The prosthetic heart valve of claim 10, furthercomprising a fenestration feature in a portion of the one or morecovers.
 12. The prosthetic heart valve of claim 11, wherein thefenestration feature comprises at least one of a radiopaque marker, anopening, a magnetic element, a one-way valve, a pop-up valve, amechanically resizable opening, and increased porosity.
 13. Theprosthetic heart valve of claim 10, wherein the one or more coversextend asymmetrically and/or non-circularly within the elongate centralpassageway and over one or more of the atrial set of arms and theventricular set of arms.
 14. The prosthetic heart valve of claim 2,wherein the atrial set of arms is attached to the atrial end of thecylindrical portion of the support structure and/or the ventricular setof arms is attached to the ventricular end of the cylindrical portion ofthe support structure.
 15. The prosthetic heart valve of claim 2,wherein the atrial set of arms is attached to the ventricular end of thecylindrical portion of the support structure and/or the ventricular setof arms is attached to the atrial end of the cylindrical portion of thesupport structure.
 16. The prosthetic heart valve of claim 15, whereinthe proximal segment of each arm of the atrial set of arms extends fromthe ventricular end of the cylindrical portion of the support structuretoward the atrial end of the cylindrical portion of the supportstructure along an exterior surface of the cylindrical portion of thesupport structure, and the distal segment of each arm of the atrial setof arms extends perpendicularly away from the central axis of theelongate central passageway.
 17. The prosthetic heart valve of claim 15,wherein the proximal segment of each arm of the ventricular set of armsextends from the atrial end of the cylindrical portion of the supportstructure toward the ventricular end of the cylindrical portion of thesupport structure along an exterior surface of the cylindrical portionof the support structure, and the distal segment of each arm of theventricular set of arms extends perpendicularly away from the centralaxis of the elongate central passageway.
 18. The prosthetic heart valveof claim 2, wherein: the distal segments of the arms of the atrial setof arms extend from an atrial longitudinal position along the exteriorsurface of the cylindrical portion of the support structure, the distalsegments of the arms of the ventricular set of arms extend from aventricular longitudinal position along the exterior surface of thecylindrical portion of the support structure, and the atriallongitudinal position is in closer proximity to the atrial end of thecylindrical portion of the support structure than the ventricularlongitudinal position is to the atrial end of the cylindrical portion ofthe support structure.
 19. The prosthetic heart valve of claim 15,wherein: in an implanted configuration in which the support structurebiodynamically fixes the prosthetic heart valve to the native leafletsof the native heart valve, the ventricular set of arms extend from theatrial end of the cylindrical portion of the support structure, througha native annulus of the native heart valve, and into the ventricularside of the native heart valve to contact the native leaflets on theventricular side of the native heart valve.
 20. The prosthetic heartvalve of claim 15, wherein: in an implanted configuration in which thesupport structure biodynamically fixes the prosthetic heart valve to thenative leaflets of the native heart valve, the atrial set of arms extendfrom the ventricular end of the cylindrical portion of the supportstructure, through a native annulus of the native heart valve, and intothe atrium of the heart to contact the native leaflets on the atrialside of the native heart valve.
 21. The prosthetic heart valve of claim2, wherein the cylindrical portion of the support structure comprises acylindrical cage structure with openings, and wherein at least someportions of the cylindrical cage structure and the openings areconfigured to receive bends of one or more arms of the atrial set ofarms and the ventricular set of arms, where the arms extendperpendicularly away from the central axis of the elongate centralpassageway.
 22. The prosthetic heart valve of claim 1, wherein theprosthetic heart valve one or more support structurescomprises onesupport structure.
 23. The prosthetic heart valve of claim 1, whereinthe prosthetic heart valve comprises more than one support structure.24. The prosthetic heart valve of claim 2, wherein a minimum innerdiameter of the cylindrical portion of the support structure thatdefines the elongate central passageway is less than a maximum outerdiameter of the elongate central passageway.
 25. The prosthetic heartvalve of claim 2, wherein a minimum diameter of a radius of curvature ofeach bend of the one or more arms of the atrial set of arms and theventricular set of arms, where the arms extend perpendicularly away fromthe central axis of the elongate central passageway, is less than themaximum outer diameter of the elongate central passageway. 26-30.(canceled)
 31. The prosthetic heart valve of claim 1, wherein thesupport structure is configured to biodynamically fix the prostheticheart valve to the native leaflets of the native heart valve of theheart such that the prosthetic heart valve is responsive to alternatingpressure differentials on either side of the native heart valve duringcardiac cycles of the heart.
 32. The prosthetic heart valve of claim 1,wherein the prosthetic heart valve is not rigidly fixed within thenative heart valve.
 33. The prosthetic heart valve of claim 4,comprising an overbite between the atrial set of arms and theventricular set of arms over the cross-sectional plane of thecylindrical portion.